- Gunnam Ravi Teja
- Ponnekanti Krishna Phani
- Sri Boni Chaitanya
- Kunala Anusha
- Afreen Shahena Sharief
- Varanasi Sindhuri
- Bukkapatnam Venkatesh
- Sunkara Mrunal Chaitanya
- Bulusu Ravi Teja
- Bhupathi Raju Kishan Varma
- Chandaka Prasanna Kumar
- Debi Prasad Pradhan
- Malineni Sushmitha
- Vellanki S. V. Sevyatha
- Angirekula Narendra
- S. Hemchand
- R. Ravi Chandra Babu
- Rajani Kaibada
- Mandula Srinivas
- Rajesh Pudi
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Annapurna, Mukthinuthalapati Mathrusri
- Determination of Raltegravir by Derivative and Difference Spectrophotometric Techniques in Film Coated Tablets
Authors
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 991-997Abstract
Eight simple spectrophotometric techniques have been proposed for the determination of Raltegravir in pharmaceutical preparations. Three zero order (D0), three first order derivative (D!) and two difference spectrophotometric methods have been developed in for the determination of Raltegravir in borate buffer (pH 9), hydrochloric acid and sodium acetate buffer solutions. Linearity has been followed over the concentration range 1-150, 10-150 and 10-150 μg/mL in all the buffers in zero order, first order derivative and difference spectroscopy respectively. All the methods were validated and can be very successfully applied for the determination of Raltegravir in pharmaceutical formulations.Keywords
Raltegravir, Spectrophotometry, Zero Order (D0), First Order Derivative (D!), Difference Spectroscopy, Validation.- New Validated RP-HPLC Method for the Determination of Vilazodone Hydrochloride–A Serotonergic Anti-Depressant
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1077-1080Abstract
A new simple liquid chromatographic method has been established for the determination of Vilazodone hydrochloride in pharmaceutical formulations. Vilazodone hydrochloride is a strong dopamine antagonist. Vilazodone hydrochloride was approved by the FDA for use in the United States to treat major depressive disorder in January 21, 2011. A mobile phase containing0.1M Ammonium formate: Methanol (20:80, v/v) with flow rate 0.7 mL/min was used for the present chromatographic study(UV detection 241 nm). Linearity was followed over the concentration range 0.1-120 μg/mL. Forced degradation studies were performed by exposing the drug Vilazodone hydrochloride to alkaline, acidic, and oxidation stress degradations. The method was validated as per ICH guidelines (ICH Guidelines 2005).
Keywords
Vilazodone Hydrochloride, RP-HPLC, Stability-Indicating, Validation.- Determination of Cabazitaxel (An Anti-Prostate Cancer Agent) by Reverse Phase Liquid Chromatography
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1138-1144Abstract
Cabazitaxel is used in the treatment of hormone-refractory prostate cancer. It is a semisynthetic taxane that can be used as a precursor molecule obtained from yew tree needles. The authors have developed a stability indicating liquid chromatographic method for the determination of Cabazitaxel in pharmaceutical products. Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector) with Zorbax SB C18 column (150 mm × 4.6 mm i.d., 3.5 μm particle size) was selected for the quantification of Cabazitaxel. A mixture of tetra butyl ammonium hydrogen sulphate and methanol was used as the mobile phase with a flow rate of 1.0 mL/min (UV detection at 210 nm). The proposed analytical method was statistically validated and forced degradation studies were conducted. Cabazitaxel has shown linearity over the concentration range 0.1-200 μg/mL with regression equation y = 26145x + 22943 (r2=0.9997) and considerable degradation was observed in acidic, alkaline and oxidation conditions. The method is specific as the resolution of Cabazitaxelwas good in presence of its degradation products. This validated stability indicating liquid chromatographic method can be used for the determination of Cabazitaxel in biological studies as well as for the pharmaceutical products.Keywords
Cabazitaxel, RP-HPLC, Tetra Butyl Ammonium Hydrogen Sulphate, Validation, Stabilityindicating.- First Order Derivative Spectrophotometric Methods for the Determination of Fluorometholone in Ophthalmic Preparations
Authors
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy,GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1145-1148Abstract
Three simple spectrophotometric techniques have been developed for the quantification of Fluorometholone in ophthalmic preparations using sodium acetate buffer (pH 4), phosphate buffer (pH 4) and phosphate buffer (pH 7) solutions. Linearity was observed over the concentration range 2-25, 2-30 and 1-50 μg/mL in sodium acetate buffer, phosphate buffer (pH 4) and phosphate buffer (pH 7) respectively. The three methods were validated and can be applied for the assay of Fluorometholone in pharmaceutical formulations.Keywords
First Order Derivative Spectrophotometry, Fluorometholone, Validation.- A New Stability Indicating RP-HPLC Method for the Determination of Apremilast-An Antirheumatic Drug
Authors
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1160-1164Abstract
A novel and simple reverse phase liquid chromatographic method has been established for the determination of Apremilast in pharmaceutical dosage forms. Apremilast is used to treat psoriatic arthritis. The proposed work was performed on Shimadzu Model CBM-20A/20 Alite with Intersil ODS3 C18 column (250 mm × 4.6 mm i.d., 5 μm particle size). A mixture of 0.1% acetic acid and acetonitrile was used as mobile phase in this method with flow rate 0.8 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. The linear regression equation was found to bey = 78597x - 14159 with correlation coefficient 0.9999. Forced degradation studies were performed by exposing the drug Apremilast to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies.Keywords
Apremilast, RP-HPLC, Validation, Stability-Indicating.- Simultaneous Determination of Ketorolac Tromethamine and Fluorometholone in Eye Drops by Spectrophotometry
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1179-1183Abstract
Four simple spectrophotometric methods have been developed for the simultaneous determination of Fluorometholone and Ketorolac tromethamine in ophthalmic preparations. Simultaneous equation method, absorbance ratio method (Q - Analysis), first derivative method and multicomponent mode of analytical techniques were selected for the determination of Fluorometholone and Ketorolac tromethamine in phosphate buffer (pH 2.0) solution. Fluorometholone and Ketorolac tromethamine has followed linearity over the concentration range 0.1-20 μg/mL and 1-20 μg/mL respectively. The methods were validated and applied for the simultaneous determination of Fluorometholone and Ketorolac tromethamine in the available pharmaceutical formulations i.e. eye drops.Keywords
Fluorometholone, Ketorolac Tromethamine, Spectrophotometry, Simultaneous Equation Method, Simultaneous Derivative, Multicomponent Analysis, Q-Analysis, Validation.- Forced Degradation Studies of Agomelatine:Development and Validation of Stability Indicating RP-HPLC Method using Internal Standard
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 3 (2017), Pagination: 703-707Abstract
Agomelatine is an anti-depressent drug. A new simple stability indicating reverse phase liquid chromatographic method has been established for the determination of Agomelatine in presence of an internal standard. Agomelatine is used for the treatment of prostate cancer. The proposed work has been performed on Shimadzu Model CBM-20A/20 Alite with Phenomenex C18 column (250 mm × 4.6 mm i.d., 5 μm particle size) using 0.1% formic acid and acetonitrile mixture as the mobile phase with flow rate 0.6 ml/min (UV detection at 205 nm). The method was validated as per ICH guidelines and the regression equation was found to be y = 0.2084x - 0.0475. Agomelatine was subjected to acidic, alkaline, oxidation, UV and thermal stress degradations and the method was reported to be robust and specific and can be applied for the assay of pharmaceutical formulations.Keywords
Agomelatine, RP-HPLC, Validation, Stability-Indicating, Bimatoprost.- New Analytical Techniques for the Determination of Epalrestat in Pharmaceutical Dosage forms by Spectrophotometry
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 3 (2017), Pagination: 739-742Abstract
Epalrestat is an aldose reductase inhibitor. Three simple, precise and accurate Spectrophotometric methods have been developed for the determination of Epalrestat in pharmaceutical formulations. Spectrophotometric analysis was performed and linearity was observed over the concentration range 0.1-25, 0.5-20 and 0.5-20 μg/ml in phosphate buffer (pH 5.0), phosphate buffer (pH 7.0) and borate buffer (pH 9.0) respectively. All the three methods were validated and can be used for the determination of Epalrestat in pharmaceutical formulations (Tablets).Keywords
Epalrestat, Phosphate Buffer and Borate Buffer, Spectrophotometry, Validation.- Stability Indicating HPLC-DAD Method for the Determination of Oxcarbazepine-An Anticonvulsant
Authors
1 Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, Andhra Pradesh-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 723-728Abstract
Oxcarbazepine is an anticonvulsant drug used for the treatment of epilepsy. It acts by decreasing the abnormal electrical activity in the brain. A new stability indicating HPLC method was developed for the quantification of Oxcarbazepine in tablets. Waters e2695 Separations module with Waters 2489 UV detector with Hypersil BDS C18 column (250 mm x 4.6 mm, 5μ) was operated with column temperature 50°C. The detector was monitored at 215 nm and the chromatographic study was run for 20 min. Linearity was observed over 5.0-150 μg/mL with linear regression equation y = 47,910x + 6493.8 with correlation coefficient R² = 0.9999. The LOQ and LOD were found to be 4.5129 μg/mL and 1.4898 μg/mL respectively. Forced degradation studies were performed for Oxcarbazepine capsules and the method was validated as per ICH guidelines.Keywords
Oxcarbazepine, RP-HPLC, Stability Indicating, Validation, ICH Guidelines.References
- Brazilian Pharmacopoeia. 4th edition. São Paulo: Atheneu. 1988.
- Flesch G. Overview of the clinical pharmacokinetics of oxcarbazepine. Clinical Drug Investigation. 24; 2004: 185-203.
- Rajendraprasad N, Basavaiah K, Cijo MX, Vinay KB, Ramesh PJ. Development and validation of stability indicating spectrophotometric methods for the determination of Oxcarbazepine in pharmaceuticals. Journal of Scientific and Industrial Research. 70; 2011: 346-351.
- Ramaa CS, Chothe PP, Naik AA, Kadam VJ. Spectrophotometric method for the estimation of Oxcarbazepine in tablets. Indian Journal of Pharmaceutical Sciences. 68; 2006: 265- 266.
- Gandhimati M, Ravi TK. Use of Folin- Ciocalteu phenol reagent and 3-methyl-2- benzothiazolinone hydrazine HCl in the determination of Oxcarbazepine in pharmaceuticals. Acta Pharmaceutica. 58; 2008: 111-118.
- Satish MA, Nagendrappa G. Spectrophotometric determination of Oxcarbazepine in pharmaceutical formulation. International Journal of Pharmaceutical Sciences. 98; 2010: 293.
- Murali Krishna Ch, Venkata Rao CV, Malleswara Rao NVS, Rambabu C. Spectrophotometric determination of Oxcarbazepine by condensation reactions using 2-chlorophenylhydrazine and anthranilic acid Journal of Pharmacy Research. 10(4); 2011: 3317-3319.
- Paula Cristina, Rezende EnÈas, Renata Barbosa de Oliveira, GersonAntÙnio Pianetti. Oxcarbazepine: Validation and application of an analytical method. Brazilian Journal of Pharmaceutical Sciences. 46(2), 265-272 (2011).
- Calvo MEB, Renedo OD, MartÌnez MJA. Determination of Oxcarbazepine by square wave ad sorptive stripping voltammetry in pharmaceutical preparations. Journal of Pharmaceutical and Biomedical Analysis. 43(3); 2007: 1156- 1160.
- Pratima AT, Supriya SJ, Satish YG. Development and validation of a novel HPTLC method for simultaneous estimation of Beta-Sitosterol-D-Glucoside and Withaferin A. International Journal of Pharmacy and Pharmaceutical Sciences. 3(2); 2011: 227-230.
- Pawar RK, Sharma Shivani, Singh KC, Sharma Rajeev KR. Development and validation of HPTLC method for the determination of Andrographolide in Kalmegh Navayas Lohaan ayurvedic formulation. International Journal of Pharmaceutical Sciences. 3(2); 2011: 85- 89.
- Reddy TS, Devi PS. Validation of a high performance thin layer chromatographic method with densitometric detection for quantitative analysis of two anticonvulsants in tablets. Journal of Planar Chromatography Modern TLC. 20; 2007; 451-456.
- Greiner-Sosanko E, Giannoutsos S, Lower DR, Virji MA, Krasowski MD. Drug monitoring: Simultaneous analysis of lamotrigine, Oxcarbazepine, 10- hydroxycarbazepine and zonisamide by HPLC-UV and a rapid GC method using a nitrogen-phosphorus detector for levetiracetum, Journal of Chromatographic Science. 45; 2007: 616-622.
- VonUnruh GE, Paar WD. Gas chromatographic/ mass spectrometric assays for Oxcarbazepine and its main metabolites, 10-hydroxy-carbazepine and carbazepine-10, 11trans-diol. Biomedical Environment Mass Spectrometry. 13(12); 1986: 6516.
- Von Unruh GE, Paar WD. Gas chromatographic assay for Oxcarbazepine and its main metabolites in plasma, Journal of Chromatography. 345(1); 1985: 67-76.
- Maurer HH, Kratzsch C, Weber AA, Peters FT, Kraemer T. Validated assay for quantification of Oxcarbazepine and its active dihydro metabolite 10- hydroxyl carbazepine in plasma by atmospheric pressure chemical ionization liquid chromatography/mass spectrometry, Journal of Mass Spectrometry. 37(7); 2002: 687-92.
- Klys M, Rojek S, Bolechala F. Determination of Oxcarbazepine and its metabolites in postmortem blood and hair by means of liquid chromatography with mass detection (HPLC/APCI/MS). Journal of Chromatography B: Analyt Technology Biomedical Life Sciences. 825(1); 2005: 38-46.
- Breton H, Cociglio M, Bressolle F, Peyriere H, Blayac JP, Hillaire BD. Liquid chromatography electro spray mass spectrometry determination of Carbamazepine, Oxcarbazepine and their metabolites in human plasma. Journal of Chromatography B: Analyt Technology Biomedical Life Sciences. 828(1-2); 2005: 80-90.
- Lanckmans K, Clinckers R, Van Eeckhaut A, Sarre S, Smolders I, Michotte Y. Use of microbore LC-MS/MS forthe quantification of Oxcarbazepine and its active metabolite in rat brain microdialysis samples. Journal of Chromatography B: Analyt Technology Biomedical Life Sciences. 831(1-2); 2006: 205-212.
- Pucci V, Kenndler E, Raggi MA. Quantitation of Oxcarbazepine and its metabolites in human plasma by micellar electrokinetic chromatography. Biomedical Chromatography 17(4), 231-8 (2003).
- Matar KM, Nicholls PJ Al Hassan MI and Tekle A. Rapid micro method for simultaneous measurement of Oxcarbazepine and its active metabolite in plasma by high-performance liquid chromatography. Journal of Clinical Pharmacy and Therapeutics. 20(4); 1995: 229-234.
- Levert H, Odou P, Robert H. LC determination of Oxcarbazepine and its active metabolite in human serum. Journal of Pharmaceutical and Biomedical Analysis. 28(3-4); 2002: 517-525.
- Juenke JM, Brown PI, Urry FM, McMillin GA. Drug monitoring and toxicology: A procedure for the monitoring of Oxcarbazepine metabolite by HPLC- UV. Journal of Chromatographic Science. 44; 2006: 45-48.
- Levert H, Odou P, Robert H. Simultaneous determination off our antiepileptic drugs in serum by high- performance liquid chromatography. Biomedical Chromatography. 16(1); 2002: 19-24.
- Rouan MC, Decherf M, Le Clanche V, Lecaillon JB and Godbillon J. Automated microanalysis of Oxcarbazepine and its monohydroxy and trans diol metabolites in plasma by liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 658(1): 1994: 167-72.
- Mandrioli R, Ghedini N, Albani F, Kenndler E, Raggi MA. Liquid chromatographic determination of Oxcarbazepine and its metabolites in plasma of epileptic patients after solid-phase extraction. Journal of Chromatography B: Analyt Technology Biomedical Life Sciences.783(1): 2003: 253-263.
- Manuela Contin, Monica Balboni, Erica Callegati, Carmina Candela, Fiorenzo Albani, Roberto Riva, Agostino Baruzzi. Simultaneous liquid chromatographic determination of lamotrigine, Oxcarbazepine mono hydroxy derivative and felbamate in plasma of patients with epilepsy. Journal of Chromatography B: Analyt Technology Biomedical Life Sciences. 828(1-2); 2005: 113-117.
- Van Belle K, Dekoster V, Sarre S, Ebinger G, Michotte Y. Liquid chromatographic assay using a micro column coupled to a U-shaped optical cell for high-sensitivity ultraviolet absorbance detection of Oxcarbazepine and its major metabolite in micro dialysates. Journal of Chromatography B: Biomedical Sciences and Applications. 657(1); 1994: 149-154.
- Menge GP, Dubois JP, Bauer G. Simultaneous determination of Carbamazepine, Oxcarbazepine and their main metabolites in plasma by liquid chromatography. Journal of Chromatography. 414(2); 1987: 477-483.
- Saracino MA, Tallarico K, Raggi MA. Liquid chromatographic analysis of Oxcarbazepine and its metabolites in plasma and saliva after a novel micro extraction by packed sorbent procedure. Analytica Chimica Acta. 661(2); 2010: 222-228.
- Volosov A, Bialer M, Xiaodong S, Perucca E, Sintov A and Yagen B. Simultaneous stereo selective high-performance liquid chromatographic determination of 10-hydroxycarbazepine and its metabolite carbamazepine-10,11-trans-dihydrodiolin human urine. Journal of Chromatography B: Biomedical Sciences and Applications. 738(2); 2000: 419-425.
- Pienimaki P, Fuchs S, Isojarvi J, Vahakangas K. Improved detection and determination of Carbamazepine and Oxcarbazepine and their metabolites by high-performance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 673(1); 1995: 97- 105.
- Souppart C, Decherf M, Humbert H, Maurer G. Development of a high throughput 9 well plate sample preparation method for the determination of trileptal (Oxcarbazepine) and its metabolites in human plasma, Journal of Chromatography B: Biomedical Sciences and Applications.762(1); 2001: 9-15.
- Hartley R, Green M, Lucock MD, Ryan S, Forsythe WI. Solid phase extraction of Oxcarbazepine and its metabolites from plasma for analysis by high performance liquid chromatography. Biomedical Chromatography 5(5); 1991: 212-215.
- Elyas AA, Goldberg VD, Patsalos PN. Simple and rapid micro analytical high performance liquid chromatographic technique for the assay of Oxcarbazepine and its primary active metabolite 10- hydroxyl carbazepine. Journal of Chromatography. 528(2); 1990: 473-479.
- Wad N. Simultaneous determination of eleven antiepileptic compounds in serum by high performance liquid chromatography. Journal of Chromatography. 305(1); 1994: 127-133.
- Menge G, Dubois JP. Determination of Oxcarbazepine in human plasma by high performance liquid chromatography. Journal of Chromatography. 275(1); 1983: 189-194.
- Vermeij TAC, Edelbroek PM. Robust isocratic high performance liquid chromatographic method for 1. simultaneous determination of seven antiepileptic drugs including lamotrigine, Oxcarbazepine and zonisamide in serum after solid phase extraction. Journal of Chromatography B. 857(1); 2007: 40-46.
- Kimiskidis V, Spanakis M, Niopas I, Kazis D, Gabrieli C, Kanaze FI, Divanoglou D. Development and validation of a high performance liquid chromatographic method for the determination of Oxcarbazepine and its main metabolites in human plasma and cerebrospinal fluid and its application to pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis. 43(2); 2007: 763-768.
- Contin M, Mohamed S, Candela C, Albani F, Riva R, Baruzzi A. Simultaneous HPLC-UV analysis of rufinamide, zonisamide, lamotrigine, Oxcarbazepine monohydroxy derivative and felbamate in deproteinized plasma of patients with epilepsy. Journal of Chromatography B. 878(3-4); 2010: 461-465.
- Pranesh Dwivedi, Savita Yadav, Janhavi Rao. Validated RP-HPLC method for the determination of related substance of Oxcarbazepine an antiepileptic drug International Journal of PharmTech Research. 9(3); 2009: 444-451.
- Rao KS, Belorkar N, Rao MEB. Development and validation of stability indicating liquid chromatographic method for the quantitative determination of Oxcarbazepine in tablet dosage forms. Journal of Young Pharmacists. 1; 2009: 270-277.
- Qi ML, Wang P, Wang LJ, Fu RN. LC method for the determination of Oxcarbazepine in Pharmaceutical preparations. Journal of Pharmaceutical and Biomedical Analysis. 31; 2003: 57- 62.
- Bhaumik U, Bose A, Chatterjee B, Ghosh A, Sengupta P, Agarwal S, Das A and Pal TK. Stability indicating HPLC method for the determination of Oxcarbazepine in pharmaceutical formulation. Asian Journal of Chemistry. 22(3); 2010: 2051-2057.
- Naidu NVS and Sivarami Reddy K. Development and validation of HPLC method for determination of Oxcarbazepine in bulk and pharmaceutical formulation. Analytical Chemistry – an Indian Journal. 15(7); 2015: 243-250.
- Fortuna A, Sousa J, Alves G, Falcão A, Soares-da-Silva P. Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma. Analytical and Bioanalytical Chemistry. 397(4); 2010:1605-1615.
- Pathy KS, Mohan A and Nadakarni S. Analytical techniques in antiepileptic drugs: Determination of assay of Oxcarbazepine by HPLC method. Research & Reviews: Journal of Hospital and Clinical Pharmacy. 3 (1); 2017: 18-35.
- ICH Q2(R1) Validation of analytical procedures: Text and methodology (2005)
- ICH Q1A (R2) Stability testing of new drug substances and products (2003).
- Enantiomeric Separation and Validation of D-Isomer in Pemetrexed Disodium–An Anti-Cancer Agent using Chiral HPLC
Authors
1 GITAM Institute of Science, GITAM(Deemed to be University), Vishakapatnam, IN
2 Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 773-786Abstract
Pemetrexed disodium is an anti-cancer agent. It is an anti-folate drug used for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. In the present study the authors have proposed a chiral HPLC method for the separation and determination of Pemetrexed disodium and its D-isomer using Chiralpak AD-H (250 x 4.6 mm, 5 μm) column within a run time of 30 mins. A mixture of n-Hexane: Ethanol: Isopropyl alcohol: TFA (250:650:100:1) was the final optimized mobile phase composition after many trials for the separation of D-isomer of Pemetrexed disodium (at 35°C) using Waters Alliance 2695 series HPLC system with 2998 photodiode array detector (UV detection at 240 nm). The method is very much useful for the pharmacokinetic studies as well as the metabolite study in vitro and in vivo for the determination of therapeutic activities of optical isomers.Keywords
Pemetrexed Disodium, HPLC, D-Isomer, Validation.References
- Jones RJ, Twelves CJ. Pemetrexed: a multi targeted antifolate (ALIMTA, LY-231514). Expert Review of Anticancer Therapy. 2; 2002:13-22.
- Shih C, Chen VJ, Gossett LS, Gates SB, MacKellar WC, Habeck LL, et al. LY231514, a pyrrolo [2,3-d] pyrimidine-based antifolate that inhibits multiple folate-requiring enzymes. Cancer Research. 57(6); 1997:1116-1123.
- Paz-Ares L, Bezares S, Tabernero JM, Castellanos D, CortesFunes H. Review of a promising new agent – pemetrexed disodium. Cancer 97(8) Suppl; 2003: 2056-2063.
- Hanauske AR, Chen V, Paoletti P, Niyikiza C. Pemetrexed disodium: A novel antifolate clinically active against multiple solid tumors. Oncologist. 6(4); 2001: 363-373.
- Bischof M,Weber KJ, Blatter J, Wannenmacher M, Latz D. Interaction of Pemetrexed disodium (ALIMTA, multi targeted antifolate) and irradiation in vitro. International Journal of Radiation Oncology, Biology, Physics 52(5); 2002: 1381-1388.
- Roland J. W. Meesters, Robin Cornelissen, Rob J. van Klaveren, Robert de Jonge, Ethan den Boer, Jan Lindemans, Theo M. Luider. A new ultrafast and high-throughput mass spectrometric approach for the therapeutic drug monitoring of the multitargeted anti-folate Pemetrexed in plasma from lung cancer patients. Analytical and Bioanalytical Chemistry, 2010, 398, (78), 2943-2948.
- Marcel P.Stoop, SabineVisser , Evertvan Dijk , Joachim G.J.V.Aerts , Bruno H.Stricker ,Theo M.Luider. A new quantification method for assessing plasma concentrations of Pemetrexed and its polyglutamate metabolites. Journal of Pharmaceutical and Biomedical Analysis. 128 (5); 2016: 1-8.
- Laurent PR, Stephen JC, Michael B, James FB. Highly sensitive analysis of the antifolate pemetrexed sodium, a new cancer agent, in human plasma and urine by high-performance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 765(2); 2001: 135-140.
- Vamsi Krishna Galla, V. Archana, Rajeswari Jinka. A new rapid stability indicating RP-PDA-UPLC method for the estimation of assay of Pemetrexed disodium-An anti-lung cancer drug from lyophilized parenteral formulation. Journal of Applied Pharmaceutical Science. 7 (10); 2017: 131-137.
- Ramulu K, Rao BM, Madhavan P, Lalitha Devi M, Srinivasu MK and Chandrasekhar KB. A validated chiral LC method for the determination of enantiomeric purity of Pemetrexed disodium on an amylose-based chiral stationary phase. Chromatographia. 65(3-4); 2007: 249-252.
- Saravanan G, Suryanarayana MV, Jadhav MJ, Ravikumar M, Someswararao N and Acharyulu PVR. A stability-indicating LC assay method for Pemetrexed disodium., 2007, 66, 431-434.
- Thahera Banu, Murali Balaram Varanasi, Mushraff Ali Khan M, Sharma JVC, Bhanu Teja B, Swaroop Kumar V and Habibuddin M. Validated reverse phase HPLC method for the determination of Pemetrexed disodium in pharmaceutical dosage forms. Oriental Journal of Chemistry. 26(4); 2010: 1325-1332.
- Rakesh Gupta K, Balakumar C, Anjaneyulu V, Karpakavalli M, Lakshmi Narayanan B, Ranjith Kumar D, Kumar EP. Development and validation of RP-HPLC method for related substance of Pemetrexed disodium. International Journal of Pharmaceutical Sciences Review and Research. 15(2); 2012: 133-137.
- Ankit DP, Shalin KP, Sen DJ and Patel CN. Development and validation of high performance liquid chromatographic and UV spectrophotometric method for estimation of Pemetrexed disodium in bulk drug and pharmaceutical formulation. International Journal of Drug Development and Research. 3(2); 2011: 301-307.
- Janaki Pathi P, Saifulla Khan P, Raveendra Reddy P and Appala Raju N. Visible spectrophotometric estimation of Pemetrexed disodium in pharmaceutical formulations. Journal of Pharmacy Research 4(2); 2011: 524-525.
- Umesh SD, Nagaraj PS, Suresh MT. Electrochemical oxidation and determination of an anticancer drug pemetrexed disodium. Asian Journal of Pharmaceutical and Clinical Research 10(3); 2017: 492-496.
- ICH Q2 (R1) Validation of analytical procedures: Text and methodology (2005).
- New Stability Indicating RP-Ultra Fast Liquid Chromatographic Method for the Determination of Perampanel–An Antiepileptic Drug
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 6 (2019), Pagination: 2657-2663Abstract
A new RP-UFLC method has been developed and validated for the determination of Perampanel in its capsules using Shimadzu Model CBM-20A/20 Alite UFLC system (Shimadzu Co., Kyoto, Japan) equipped with SPD M20A prominence photodiode array detector on C8 (2) 100A (Luna) column (250 mm×4.60 mm i.d. 5μm particle size)maintained at room temperature. Mobile phase consisting of a mixture of water, acetonitrile and 0.1% acetic acid (50:50:0.1 v/v) was chosen with a flow rate of 1 mL/min (UV detection at 215nm) on isocratic mode. Perampanel obeys Beer-Lambert’s law over the concentration range 0.05–120 μg/mL with linear regression equation y=73084x+13800 (r2=0.9999). Forced degradation studies were performed and the method was validated as per ICH guidelines.Keywords
Perampanel, RP-UFLC, Stability Indicating, Validation, ICH Guidelines.References
- Greenwood J, Valdes J. Perampanel (Fycompa) a review of clinical efficacy and safety in epilepsy. P. T. 41; 2016: 683-698.
- Franco V, Crema F, Iudice A, et al. Novel treatment options for epilepsy: focus on Perampanel. Pharmacol Res. 70; 2013: 35-40.
- Patsalos PN. The clinical pharmacology profile of the new antiepileptic drug Perampanel: a novel noncompetitive AMPA receptor antagonist. Epilepsia. 56; 2015:12-27.
- Ugo de Grazia, Annachiara D' Urso, Federica Ranzato, Valentina De Riva, Giorgia Contarato, Giuseppe Billo, Francesco Perini, Elisabetta Galloni. A liquid chromatography-mass spectrometry assay for determination of Perampanel and concomitant antiepileptic drugs in the plasma of patients with epilepsy compared with a fluorescent HPLC assay. Therapeutic Drug Monitoring. 40(4); 2018: 477-485.
- Mano Y, Takenaka O and Kusano K.High-performance liquid chromatography-tandem mass spectrometry method for the determination of Perampanel, a novel α- amino-3- hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist in human plasma. J. Pharm. Biomed. Anal. 107; 2015: 56-62.
- Franco, Valentina; Marchiselli, Roberto; Fattore, Cinzia; Tartara, Elena; De Sarro, Giovambattista; Russo, Emilio; Perucca, Emilio. Development and validation of an HPLC-UV assay for the therapeutic monitoring of the new antiepileptic drug Perampanel in human plasma. Therapeutic. Drug Monitoring. 38(6); 2016: 744-750.
- Mano Y. An inter-laboratory cross-validation study for determination of Perampanel in human plasma by liquid chromatography assays. Biomedical Chromatography. 30(12); 2016: 2067-2069.
- Susan Mohamed, Carmina Candela, Roberto Riva and Manuela Contin. Simple and rapid validated HPLC-fluorescence determination of Perampanel in the plasma of patients with epilepsy. Practical Laboratory Medicine. 10; 2018:15-20.
- Mano Y, Takenaka O, Kusano K. HPLC with fluorescence detection assay of Perampanel, a novel AMPA receptor antagonist, in human plasma for clinical pharmacokinetic studies. Biomedical Chromatography. 29(10); 2015: 1589-1593.
- ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.
- ICH Validation of analytical procedures: Text and methodology Q2(R1), International Conference on Harmonization, 2005.
- New RP-UPLC method for The Simultaneous Determination of Haloperidol and Benzhexol in Tablets
Authors
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 6 (2019), Pagination: 2847-2850Abstract
Haloperidol is an anti-psychotic drug and Benzhexol (Trihexyphenidyl) is an anticholinergic drug. A newstability indicating UPLC method has been developed for the simultaneous determination of Haloperidol and Benzhexol and the method was validated. Waters UPLC with Empower software, with Acquity UPLC SB C18 x 1.7μ. column and PDA detector was used for the simultaneous determination of Haloperidol and Benzhexol. A mixture of phosphate buffer and Acetonitrile taken in the ratio 56:44 v/v was used as mobile phase with a flow rate of 0.2 ml/min (UV detection at 245 nm) (Injection volume 1μl). Haloperidol and Benzhexol have shown linearregression equations, y=13361x+476.2(R² = 0.9998) and y =10609 x + 899.5 (R² = 0.9998). The LOD and LOQ are found to be 0.03 μg/mL and 0.10 μg/mL for Haloperidol and 0.03μg/mL and 0.09 μg/mL for Benzhexolrespectively. The present liquid chromatographic method is precise, accurate and can be used for the simultaneous estimation of Haloperidol and Benzhexol tablets.Keywords
Haloperidol, Benzhexol (Trihexyphenidyl), RP-UPLC, Isocratic Mode, Validation.References
- British Pharmacopoeia, London, The British Pharmacopoeia Commission. 1; 2008:1047.
- Indian Pharmacopoeia, New Delhi, The Controller of Publications, Govt of India. 1; 1996: 91.
- Bognar IT, Altes U, Beinhauer C, Kessler I, Fuder H. A muscarinic receptor different from the M1, M2, M3 and M4 subtypes mediates the contraction of the rabbit iris sphincter. Naunyn Schmiedebergs Arch Pharmacol. 345(6); 1992: 611-618.
- Dorje F, Wess J, Lambrecht G, Tacke R, Mutschler E, Brann MR: Antagonist binding profiles of five cloned human muscarinic receptor subtypes. J Pharmacol Exp Ther. 256(2); 1991: 727-733.
- Srikantha D and Ramesh Raju R.A RP-HPLC method for simultaneous determination of Haloperidol and Trihexyphenidyl hydrochloride in tablet dosage form. Asian Journal of Pharmaceutical and Clinical Research. 7; Suppl 7; 2014: 14-18.
- Amulya E, Naveen Kumar N, Mounika CH, Kowmudi V, Supriya N, Ramya Madhuri K. Development and validation of RP-HPLC method for the simultaneous estimation of Haloperidol and Trihexyphenidyl in API and combined tablet dosage form. International Journal of Applied Pharmaceutical Sciences and Research. 3 (3); 2018: 36-40.
- Wate SP, Borkar AA. RP-HPLC estimation of Haloperidol and Trihexyphenidyl HCl in tablets. International Journal of Chem Tech Res. 1(3); 2009: 675-676.
- Wate SP, Borkar AA. Simultaneous spectrophotometric estimation of Haloperidol and Trihexyphenidyl HCL in tablets. Indian Journal of Pharmaceutical Sciences. 72(2); 2010:265-267.
- Manoj Charde, Imran Sheikh, Sarika Dhole and Avinash. V. Kasture. Simultaneous Estimation of Benzhexol hydrochloride and Haloperidol by absorbance correction method. Journal of Pharmacy Research. 3(9); 2010: 2099-2101.
- ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
- Stability Indicating LC-TQ-ESI-MS Method for the Quantification of Racecadotril in Presence of its Degradants
Authors
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 7 (2019), Pagination: 3437-3443Abstract
Racecadotril is an anti-diarrheal drug. Waters Alliance e2695 with PDA detector (2998) Zorbax SB C18 column (150 x 4.6 mm, 3.5 μm) (Isocratic mode) was used for the quantification of Racecadotril. A mixture of water and Acetonitrile (50:50) was used as diluent and the injection volume was 20 μl. The flow rate was 1.0mL/min (Detection wave length 230 nm). Linearity was evaluated in the concentration range 1-360 μg/ml with regression equation y = 14710 x+9958.9(Correlation coefficient R² = 0.9996). The LOD and LOQ were found to be 0.2942 μg/mL and 0.9694 μg/mL respectively. Forced degradation studies were conducted for Racecadotril capsules and method validation was performed as per ICH guidelines.Keywords
Racecadotril, LC-TQ-MS, Forced Degradation Studies, Validation, ICH Guidelines.References
- Budavari.S, Eds., In; the Merck Index, 13th Edn., Merck Research Laboratories, Division of Merck and Co., Inc., NJ.,2001, 1450.
- Prabu S, Singh T, Joseph A, Kumar C and Shirwaikar A. Determination of Racecadotril by HPLC in capsules. Indian Journal of Pharmaceutical Sciences. 69(6); 2007: 819-821.
- Anton Smith A, Madhusudhana Reddy I, Varaprasad K1 and Manavalan R. Development and validation of a rapid RP-HPLC method for the determination of Racecadotril in formulation. International Journal of Chem Tech Res. 1(4): 2009: 1090-1093.
- Pramadvara Kallepalli and Mukthinuthalapati Mathrusri Annapurna. New stability indicating liquid chromatographic method for the quantification of Racecadotril (An Anti-Diarrheal drug). Research Journal of Pharmacy and Technology. 11(8); 2018: 3679-3684.
- Pawan K Basniwal, Prabhat K Srivastava, Surendra K Jain and Deepti Jain,RP-LC analysis and hydrolytic degradation profile of Racecadotril, Journal of Chromatogr. 68; 2008: 641-647.
- Mathrusri Annapurna M, Narendra A and Alok Sahu. Development and validation of a stability-indicating RP-HPLC method for analysis of Racecadotril in pharmaceutical dosage forms. Chemical Science Transactions. 3(2); 2014: 518-529.
- Mohamed AO, Fouad MM, Hasan MM, Abdel Razeq SA and Elsherif Z A. Stability-indicating methods for the determination of Racecadotril in the presence of its degradation products. National Center for Biotechnology Information. 3; 2009: 247-252.
- Seshagiri Rao JVLN, Bhanu Prakash P, Muralikrishna M and Ravikumar P. RP-HPLC method for the estimation of Racecadotril in bulk and in tablets. Asian Journal of Chemistry. 19(4); 2007: 2623-2626.
- Anupama B, Sai Pavan P, Madhubabu M and Viswanath A. Development and validation of RP-HPLC method for the analysis of Racecadotril in pure and formulation. International Research Journal of Chemistry. 2(1); 2011: 163-168.
- Pintoo Tank, Aarti Zanwar, A.K. Seth and Sharad Kumar. Development of new analytical methods for quantitative estimation of Racecadotril as an active pharmaceutical ingredient by UV spectrophotometer. International Journal of Pharmaceutical Sciences and Research. 3(5); 2012: 1495-1497.
- Vetrichelvan T and Prabakaran S. New spectrophotometric methods for the determination of Racecadotril in bulk drug and capsules. Indian Journal of Pharm Sci. 69(2); 2007: 307-309.
- Lakshmana Rao A, Rajeswari KR and Sankar GG. Spectrophotometric methods for the determination of selected drugs in pharmaceutical formulations. J Chem Pharm Res. 2(1); 2010: 280-282.
- Reddy KM, Babu JM, Sudhakar P, Sharma MS, Reddy GS, Vyas K. Structural studies of Racecadotril and its process impurities by NMR and mass spectroscopy. Pharmazie. 61(12); 2006: 994-998.
- Vishnuvardhan Chiguru, Allakonda Lingesh, Srinivas R, Satheeshkumar N. Forced degradation study of Racecadotril: Effect of co-solvent, characterization of degradation products by UHPLC-Q-TOF-MS/MS, NMR and cytotoxicity assay. Journal of Pharm Biomed Anal. 128; 2016: 9-17.
- Xu.F, Yang.L, Xu.G, A rapid and validated HPLC method to quantify Racecadotril metabolite, thiorphan, in human plasma using solid-phase extraction. Journal of Chromatogr B. Analyt Technol Biomed life Sciences. 861(1); 2007: 130-135.
- Fan Xua, Lingli Yangb and Guili Xua.A rapid and validated HPLC method to quantify Racecadotril metabolite, thiorphan, in human plasma using solid-phase extraction. Journal of Chromatogr B. 861(1); 2008: 130-135.
- Xu.Y, Huang.J, Liu.F, Guo.S, Guo.Q, Quantitative analysis of Racecadotril metabolites in human plasma using a liquid chromatography /Tandem mass spectrometry, Journal of Chromatogr B Analyt Technol Biomed life Sciences. 812(1-2); 2007: 101-107.
- ICH validation of analytical procedures: text and methodology Q2 (R1), International Conference on Harmonization, 2005.
- ICH stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization, 2003.