Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

A Validated Ultra Performance Liquid Chromatography Method for Simultaneous Estimation of Diacerein and Aceclofenac in Bulk and Pharmaceutical Formulation


Affiliations
1 Faculty of Pharmacy, Mandsaur University, Mandsaur, Madhya Pradesh, India
     

   Subscribe/Renew Journal


A simple, exceptionally cost-effective, extremely accurate, quite precise and highly reproducible analytical method was developed and validated for simultaneous estimation of Diacerein and Aceclofenac in bulk and Pharmaceutical formulation. The new Ultra Performance Liquid Chromatography technique was developed. Method- The separation has been done on column ACQUITY UPLC BEH Shield C18 (50 x 2.1mm), 1.7μm (40°C temperature). The mobile phase contained Buffer and Acetonitrile (Buffer: ACN) (55:45 V/V).. The flow rate was set at 0.4ml/min, and detected at 268nm with PDA detector. Mobile phase was sonicated for 15 min. before use. 5μl of samples of standard stock solution and tablet solution were injected. Different trials were performed to separate diacerein and aceclofenac. The total run time of the detection was 4 min. The developed method was validated against different validation parameters. Results - The retention times were obtained at 1.762min. and 2.891 min. for Diacerein and Aceclofenac respectively. Accuracy study was observed in the range of 100.33% to 101.67% with less than 2% RSD. LOQ was found to be 2.98μg/ml and 5.9041μg/ml. similarly LOD was found to be 0.9841μg/ml and 1.9467μg/ml. for Diacerein and Aceclofenac respectively. Precision %RSD for intraday and interday were found to be 0.19 and 0.18 for Diacerein , 0.44 and 0.16 for Aceclofenac respectively. Linearity was found in the range of 2.5-17.5μg/ml and 5-35μg/ml for Diacerein and Aceclofenac respectively. The method was found robust by deliberate changes in the flow rate, ratio of mobile phase and detection wavelength. Conclusion-The method was found to be satisfactory and can be used successfully for determination of Diacerein and Aceclofenac simultaneously in bulk and pharmaceutical dosage form.

Keywords

UPLC, Diacerein, Aceclofenac, Anti-inflammatory, Method development.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Tamura T, Ohmori K. Rhein an Active Metabolite of Diacerhein Suppresses the Interleukin-1 Induced proteoglycan degradation in cultured rabbit articular chondrocytes. Japanes Journal of Pharmacology. 2001; 85: 101–104. doi: 10.1254/jjp.85.101.

  • Sweetman SC. Martindale: The Complete Drug Reference, 35th ed., London, UK: Pharmaceutical Press; 2007: 35-36.

  • Government of India Ministry of Health & Family Welfare. Indian Pharmacopoeia. 5th Ed. Ghaziabad (INDIA): The Indian Pharmacopoeia Commission; 2007; 2. P. 63-64.

  • Sharma MC, Sharma S. Stability and Reverse Phase HPLC Assay Method For Determination of Diacerein and Aceclofenac In Tablet Dosage Form - Application To Dissolution Studies. Asian Journal of Pharmaceutical and Clinical Research. 2011;4(1): 31-34. idosi.org/aejsr/6(3)11/5.

  • Ojha A, Rathod R, Padh H. Simultaneous HPLC–UV determination of rhein and aceclofenac in human plasma. Journal of Chromatography B. 2009; 877:1145–1148. DOI: 10.1016/j.jchromb.2009.02.061

  • Hinz B, Auge D, Rau T. Rietbrock S, Brune K, Werner U. Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high-performance liquid chromatography. Biomedical Chromatography. 2003;17:268–275. doi.org/10.1002/bmc.243

  • Godse VP, Deodhar MN, Bhosale AV, Sonawane RA, Sakpal PS, Borkar DD, Bafana YS. Reverse Phase HPLC Method for Determination of Aceclofenac and Paracetamol in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2009;2:37–40. DOI:10.4103/0250-474X.26672

  • Hasan NY, Abdel-Elkawy M, Elzeany BE and Wagieh. Stability indicating methods for the determination of aceclofenac. IL Farmaco. 2003; 58: 91-99. doi.org/10.1016/S0014-827X(02)01271-5.

  • Borgmann SHM, Parcianello L, Arend MZ, Bajerski L, Cardoso G. Development and Validation of a Dissolution Method with Spectrophotometric Analysis for Diacerhein Capsules. Scientia Pharmaceutica. 2008;76:541–554. doi.org/10.3797/scipharm.0804-17

  • Nyola NK, Kalra N. Spectrophotometric determination of diacerin in bulk and pharmaceutical formulation. International journal of Pharma and Bio Sciences. 2010; 1(4):202-07.

  • Dhaduk DM, Rathod BG, Patel PB. Estimation of Sildenafil Citrate and Diacerein Hydrochloride in their Combined Dosage Form by Validated UV Spectroscopic method. Inventi Rapid: Pharm Analysis & Quality Assuranc. 2012;5(10): 337.

  • Bhinge JR, Kumar RV, Sinha VR. A simple and sensitive stability indicating RP-HPLC assay method for the determinationofaceclofenac.JournalofChromatographicScience.2008;46:440444. doi.org/10.1093/chromsci/46.5.440

  • Momin MY, Yeole PG, Puranik MP, Wadher SJ. Reverse phase HPLC method for determination of aceclofenac and paracetamol in tablet dosage form. Indian Journal of Pharmaceutical Sciences. 2006;68:387–389. DOI: 10.4103/0250-474X.26672

  • Karthikeyan V, Yuvaraj V, Nema RK. Simultaneous estimation of paracetamol, chlorzoxazone and aceclofenac in pharmaceutical formulation by HPLC method. International Journal of ChemTech Research. 2009;1:457–460.

  • Kachhadia PK, Doshi AS, Ram VR, Joshi HS. Validated LC Method for Simultaneous Analysis of Tramadol HydrochlorideandAceclofenacinaCommercialTablet.Chromatographia.2008;68:997 52.doi: 10.3797/scipharm.1108-04

  • Gandhi SP, Dewani MG, Borole TC, Damle MC. Development and Validation of Stability Indicating HPTLC Method for Determination of Diacerein and Aceclofenac as Bulk Drug and in Tablet Dosage Form. European journal of Advanced chemistry research. 2012; 9(4): 2023-28.

  • Chaudhari B, Daniel K. A Validated RP-HPLC Method for Simultaneous Estimation of Tizanidine and Nimesulide in Bulk and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 13(9): September 2020. 4207-4212. doi: 10.5958/0974-360X.2020.00743.

  • The International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedure: Text and Methodology: 2005.

  • Validation of analytical procedures: text and methodology (2005) 254 In: ICH Harmonized Tripartite Guidelines Q2 (R1). ICH, Swtizerland.

  • Padmaja V, Swapna G, Prasanthi M. Stability Indicating UPLC Method Development and Validation for the Determination of Reserpine in Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology. 2018; 11(11): 5111-5114. doi: 10.5958/0974-360X.2018.00933.2

  • Khan H, Ali M, Ahuja A, Ali J. Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Human Plasma. Research Journal of Pharmacy and Technology. 2016; 9(9):1441-1446. DOI: 10.5958/0974-360X.2016.00278.X

  • Eswarudu MM, Eswaraiah MC, Prasanna Kumar K, Sudhakar K. Ultra Performance Liquid Chromatography (UPLC): A Preeminent Technique in Pharmaceutical Analysis. Research Journal of Pharmacy and Technology. 2012; 5(12): 1484-1489.

  • Swetha Sri R, Bhavya Sri K, Mounika. A Review on Comparative study of HPLC and UPLC. Research Journal of Pharmacy and Technology. 2020; 13(3):1570-1574. DOI: 10.5958/0974-360X.2020.00284.X

  • Dhalape VM, Santosh T, Khadangale R, Pinjari V. RP-HPLC Method Validation for Quantitative Analysis of Pemetrexed Disodium Hemipentahydrate. Research Journal of Pharmacy and Technology. 2020; 13(8):3685-3689. DOI: 10.5958/0974-360X.2020.00652.6


Abstract Views: 140

PDF Views: 0




  • A Validated Ultra Performance Liquid Chromatography Method for Simultaneous Estimation of Diacerein and Aceclofenac in Bulk and Pharmaceutical Formulation

Abstract Views: 140  |  PDF Views: 0

Authors

Bharatee P. Chaudhari
Faculty of Pharmacy, Mandsaur University, Mandsaur, Madhya Pradesh, India
Kratika Daniel
Faculty of Pharmacy, Mandsaur University, Mandsaur, Madhya Pradesh, India

Abstract


A simple, exceptionally cost-effective, extremely accurate, quite precise and highly reproducible analytical method was developed and validated for simultaneous estimation of Diacerein and Aceclofenac in bulk and Pharmaceutical formulation. The new Ultra Performance Liquid Chromatography technique was developed. Method- The separation has been done on column ACQUITY UPLC BEH Shield C18 (50 x 2.1mm), 1.7μm (40°C temperature). The mobile phase contained Buffer and Acetonitrile (Buffer: ACN) (55:45 V/V).. The flow rate was set at 0.4ml/min, and detected at 268nm with PDA detector. Mobile phase was sonicated for 15 min. before use. 5μl of samples of standard stock solution and tablet solution were injected. Different trials were performed to separate diacerein and aceclofenac. The total run time of the detection was 4 min. The developed method was validated against different validation parameters. Results - The retention times were obtained at 1.762min. and 2.891 min. for Diacerein and Aceclofenac respectively. Accuracy study was observed in the range of 100.33% to 101.67% with less than 2% RSD. LOQ was found to be 2.98μg/ml and 5.9041μg/ml. similarly LOD was found to be 0.9841μg/ml and 1.9467μg/ml. for Diacerein and Aceclofenac respectively. Precision %RSD for intraday and interday were found to be 0.19 and 0.18 for Diacerein , 0.44 and 0.16 for Aceclofenac respectively. Linearity was found in the range of 2.5-17.5μg/ml and 5-35μg/ml for Diacerein and Aceclofenac respectively. The method was found robust by deliberate changes in the flow rate, ratio of mobile phase and detection wavelength. Conclusion-The method was found to be satisfactory and can be used successfully for determination of Diacerein and Aceclofenac simultaneously in bulk and pharmaceutical dosage form.

Keywords


UPLC, Diacerein, Aceclofenac, Anti-inflammatory, Method development.

References