Research Journal of Pharmacy and Technology

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Spectrophotometric Resolution and Quantification of Ternary Co-formulated Mixture of Thioctic acid, Benfotiamine and Cyanocobalamin


Affiliations
1 Analytical Chemistry Department, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt
2 Pharmaceutical Chemistry Department, Future University in Egypt, 90th St., Fifth Settlement, New Cairo, 11835 Cairo, Egypt
     

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Four spectrophotometric methods were developed and validated for spectral resolution and determination of thioctic acid (THC), benfotiamine (BEN) and cyanocobalamin (CNCo) in their pure form, laboratory prepared mixtures and capsules. Method A, a first derivative method for determination of CNCo, by recording the peak amplitude at 564.0 nm. Method B, is a Ratio difference spectrophotometric one which is applied for determination of THC and BEN, where CNCo has no interference. Method C applied first derivative of ratio spectra where THC and BEN were determined by recording the peak amplitude at 330.8 and 286.8 nm, in order. Method D a Ratio subtraction method that was successfully determines BEN at its λmax without interference of the other co-formulated drugs. Validation according to ICH guidelines was performed. The linearity ranges were 200.00-1800.00, 2.00-30.00 and 10.00-200.00 μg/mL for THC, BEN and CNCo, in a respective order. The methods were found to be accurate, precise and specific.

Keywords

Derivative, Ratio Difference, Thioctic Acid, Benfotiamine, Cyanocobalamin.
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  • The British Pharmacopoeia. 2015: The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MEHRA)-© Crown Copyright.

  • Martindale, The Complete Drug Reference, . 37 ed. Vol. A. 2011: Pharmaceutical Press.

  • Walash M, Metwally M-S, El-Brashy A, and Abdelal A. Kinetic Spectrophotometric Determination of Some Sulfur Containing Compounds in Pharmaceutical Preparations and Human Serum. Il Farmaco. 2003; 58(12): 1325-1332.

  • Walash M, El-Brashy A, Metwally M, and Abdelal A. Spectrophotometric and Kinetic Determination of Some Sulphur Containing Drugs in Bulk and Drug Formulations. B. Kor. Chem. Soc. 2004; 25(4): 517-524.

  • El-Enany N, Belal F, and Rizk M. Spectrophotometric Determination of Thioctic Acid in its Dosage Forms Through Complex Formation with Pd (II). J. Chin. Chem. Soc-Taip. 2007; 54(4): 941-948.

  • Korićanac Z, Čakar M, Tanasković S, and Jovanović T. Spectrophotometric Determination of Thioctic (α-Lipoic) Acid in Water and Pharmaceutical Preparations. J. Serb. Chem. Soc. 2007; 72(1): 29-35.

  • Taha EA, Hassan NY, Aal FA, and Fattah LE-SA. Fluorimetric Determination of Some Sulfur Containing Compounds Through Complex Formation with Terbium (Tb+ 3) and Uranium (U+ 3). J. Fluoresc. 2007; 17(3): 293-300.

  • Ibrahim F, Ali F, Ahmed S, and Tolba M. Kinetic Spectrofluorometric Determination of Thioctic Acid in Bulk and Pharmaceutical Preparations Via its Oxidation with Cerium (IV). J. Chin. Chem. Soc-Taip. 2007; 54(4): 925-932.

  • Satoh S, Toyo’oka T, Fukushima T, and Inagaki S. Simultaneous Determination of α-Lipoic Acid and its Reduced Form by High-Performance Liquid Chromatography with Fluorescence Detection. J. Chromatogr. B. 2007; 854(1): 109-115.

  • Durrani AI, Schwartz H, Nagl M, and Sontag G. Determination of Free α-Lipoic Acid in Foodstuffs by HPLC Coupled with CEAD and ESI-MS. Food Chem. 2010; 120(4): 1143-1148.

  • Khan A, Khan MI, Iqbal Z, Ahmad L, Shah Y, and Watson DG. Determination of Lipoic Acid in Human Plasma by HPLC-ECD Using Liquid–Liquid and Solid-Phase Extraction: Method Development, Validation and Optimization of Experimental Parameters. J. Chromatogr. B. 2010; 878(28): 2782-2788.

  • Siangproh W, Rattanarat P, and Chailapakul O. Reverse-Phase Liquid Chromatographic Determination of α-Lipoic Acid in Dietary Supplements Using a Boron-Doped Diamond Electrode. J. Chromatogr. A. 2010; 1217(49): 7699-7705.

  • Poongothai S, Ilavarasan R, and Karrunakaran C. Simultaneous and Accurate Determination of Vitamins B1, B6, B12 and Alpha-Lipoic Acid in Multivitamin Capsule by Reverse-Phase High Performance Liquid Chromatographic Method. Int. J. Pharm. Pharm. Sci. 2010; 2(S4): 133-9.

  • Khan A, Iqbal Z, Watson DG, Khan A, Khan I, Muhammad N, Muhammad S, Nasib HA, Iqbal N, and Kashif M. Simultaneous Determination of Lipoic Acid (LA) and Dihydrolipoic Acid (DHLA) in Human Plasma Using High-Performance Liquid Chromatography Coupled with Electrochemical Detection. J. Chromatogr. B. 2011; 879(20): 1725-1731.

  • Kumar SA, Debnath M, Rao JS, and Sankar DG. A new, simple, sensitive, accurate and rapid analytical method development and validation for simultaneous estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in bulk as well as in pharmaceutical dosage form by using RP-HPLC. Asian J. Res. Chem. 2014; 7(4): 426-433.

  • Kumar SA, Debnath M, Rao JS, and Sankar DG. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Pregabalin, Mecobalamin and Alpha Lipoic Acid in Bulk as well as in Pharmaceutical Dosage Form by using RP-HPLC. Research J. Pharm. and Tech. 2014; 7(9): 7.

  • Vani R, Kumar BV, and Mohan GK. Analytical Method Development and Validation for the Determination of Allopurinol and Alphalipoic Acid Using Reverse Phase HPLC Method in Bulk and Tablet Dosage Form. Research J. Pharm. and Tech. 2015; 8(2): 207.

  • Corduneanu O, Garnett M, and Brett AMO. Anodic Oxidation of α-Lipoic Acid at a Glassy Carbon Electrode and Its Determination in Dietary Supplements. Anal. Lett. 2007; 40(9): 1763-1778.

  • Abbas M and Radwan A. Novel Lipoate-Selective Membrane Sensor for the Flow Injection Determination of α-Lipoic Acid in Pharmaceutical Preparations and Urine. Talanta. 2008; 74(5): 1113-1121.

  • Miranda M, Del Rio R, Del Valle M, Faundez M, and Armijo F. Use of Fluorine-Doped Tin Oxide Electrodes for Lipoic Acid Determination in Dietary Supplements. J. Electroanal. Chem. 2012; 668(2012): 1-6.

  • Tan X, Li Q, Zhang X, Shen Y, and Yang J. A Novel and Sensitive Turn-On Fluorescent Biosensor for the Determination of Thioctic Acid Based on Cu 2+-Modulated N-Acetyl-l-Cysteine Capped CdTe Quantum Dots. RSC Adv. 2015; 5(55): 44173-44182.

  • Hegazy MA, Abdelwahab NS, and Fayed AS. A Novel Spectral Resolution and Simultaneous Determination of Multicomponent Mixture of Vitamins B1, B6, B12, Benfotiamine and Diclofenac in Tablets and Capsules by Derivative and MCR–ALS. Spectrochim. Acta A. 2015; 140: 524-533.

  • Agrawal O and Telang N. Development and Validation of UV Spectrophotometric Method for Estimation of Benfotiamine in Bulk and Dosage Form. Asian J. Pharm. Anal. 2016; 6(3): 133-137.

  • Adithya BP and Mahesh MVJ. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Benfotiamine and Metformin hydrochloride in Tablet Dosage Form. RGUHS J. Pharm. Sci. 2012; 2(4): 87-91.

  • Adithya BP and Vijayalakshmi M. Development and Validation of RP-HPLC Method for the Estimation of Benfotiamine in Bulk and Dosage Form. Int. J. Pharm., Chem. Biol. Sci. 2012; 2(3): 354-360.

  • Nanaware DA, Bhusari VK, and Dhaneshwar SR. Validated HPLC Method for Simultaneous Quantitation of Benfotiamine and Metformin Hydrochloride in Bulk Drug and Formulation. Int. J. Pharm. Pharm. Sci. 2013; 5(2): 138-42.

  • Hadad G, Salam RA, and Hameed EA. Application of LC and HPTLC-Densitometry for the Simultaneous Determination of Two Multicomponent Mixtures Containing Pyridoxine Hydrochloride and Cyanocobalamine. Acta Chromatogr. 2013; 25(3): 431-450.

  • Kim J, Hopper CP, Connell KH, Darkhal P, Zastre JA, and Bartlett MG. Development of A Novel Method for the Bioanalysis of Benfotiamine and Sulbutiamine in Cancer Cells. Anal. Methods-UK. 2016; 8(28): 5596-5603.

  • Fayed AS, Hegazy MA-M, and Wahab NSA. Chromatographic Analysis of a Multicomponent Mixture of B1, B6, B12, Benfotiamine, and Diclofenac; Part I: HPLC and UPLC Methods for the Simultaneous Quantification of These Five Components in Tablets and Capsules. J. AOAC Int. 2016; 99(6): 1513-1521.

  • Fayed AS and Hegazy MA-M. Chromatographic Analysis of Multicomponent Mixture of Vitamins B1, B6, B12, Benfotiamine and Diclofenac; Part II: LC-Tandem MS/MS Method for Simultaneous Quantification of Five Components Mixture in Pharmaceutical Formulations and Human Plasma. RSC Adv. 2016; 6(45): 39409-39423.

  • Sakhare RS, Pekamwar SS, and Mohkare DP. Development and Validation of Stability Indicating HPTLC Method for the Determination of Metformin Hydrochloride and Benfotiamine in Bulk and Combined Dosage Form. Indian J. Pharm. Educ. 2017; 51(2): S8-S16.

  • Karşilayan H. Quantitation of Vitamin B12 by First-Derivative Absorption Spectroscopy. Spectrochim. Acta A. 1996; 52(9): 1163-1168.

  • Elzanfaly ES, Nebsen M, and Ramadan NK. Development and Validation of PCR, PLS, and TLC Densitometric Methods for the Simultanous Determination of Vitamins B1, B6 and B12 in Pharmaceutical Formulations. Pak. J. Pharm. Sci. 2010; 23(4): 409-415.

  • Li H-B and Chen F. Determination of Vitamin B12 in Pharmaceutical Preparations by A Highly Sensitive Fluorimetric Method. Fresen. J. Anal. Chem. 2000; 368(8): 836-838.

  • Song Z and Hou S. Sub-Picogram Determination of Vitamin B12 in Pharmaceuticals and Human Serum Using Flow Injection with Chemiluminescence Detection. Anal. Chim. Acta. 2003; 488(1): 71-79.

  • Kucukkolbasi S, Bilber O, Ayyildiz HF, and Kara H. Simultaneous and Accurate Determination of Water-and Fat-Soluble Vitamins in Multivitamin Tablets by Using An RP-HPLC Method. Quím. Nova. 2013; 36(7): 1044-1051.

  • Abano E and Dadzie RG. Simultaneous Detection of Water-Soluble Vitamins Using the High Performance Liquid Chromatography (HPLC)-a review. Croat. J. Food Sci. Technol. 2014; 6(2): 116-123.

  • Antakli S, Sarkees N, and Sarraf T. Determination of Water-Soluble Vitamins B1, B2, B3, B6, B9, B12 and C on ODS Column 5 μm by High Performance Liquid Chromatography with UV-DAD Detection. Asian J. Chem. 2014; 26(20): 7035-7039.

  • Tomčik P, Banks CE, Davies TJ, and Compton RG. A Self-Catalytic Carbon Paste Electrode for The Detection of Vitamin B12. Anal. Chem. 2004; 76(1): 161-165.

  • Chen J-H and Jiang S-J. Determination of Cobalamin in Nutritive Supplements and Chlorella Foods by Capillary Electrophoresis− Inductively Coupled Plasma Mass Spectrometry. J. Agr. Food Chem. 2008; 56(4): 1210-1215.

  • Salem H. LC Simultaneous Determination of Thioctic Acid, Benfotiamine and Cyanocobalamin in Thiotacid Compound Capsules. Chromatographia. 2010; 72(3-4): 327-330.

  • Bhatia NM, Deshmane SJ, More HN, and Choudhari PB. Simultaneous Spectrophotometric Estimation of the Amlodipine Besylate and Hydrochlorothiazide in Pharmaceutical Preparations and Biological Samples. Asian J. Res. Chem. 2009; 2(4): 394-397.

  • Vijayalakshmi R, Archana S, and Dhanaraju M. A Simultaneous Estimation of Perindopril and Losartan in Solid Dosage Forms by UV Spectrophotometry. Asian J. Res. Chem. 2010; 3(3): 571-573.

  • Seervi C, Pawar K, Dhabale P, Gonjari I, Raut C, and Gharge D. Development and Validation of UV Spectrophotometric Method of Ambroxol Hydrochloride in Bulk and Pharmaceutical Formulation. Asian J. Res. Chem. 2009; 2(4): 547-549.

  • Sharma M, Sharma A, Jain A, and Banerjee P. Spectrophotometric Estimation of Valsartan in Tablet Dosage Form. Asian J. Res. Chem. 2009; 2(4): 464-466.

  • Bhadoriya A, Padekar S, Patil V, Shinde S, Choudhari V, and Kuchekar B. Development and Validation of Ratio Spectra Derivative Spectrophotometric Method for Determination of Ternary Mixture of Aspirin, Atenolol and Amlodipine Besylate in Formulation. Asian J. Res. Chem. 2010; 3: 562-565.

  • Chabukswar A, Shinde S, Kuchekar B, Jagdale S, Lokhande P, Choudhari V, and Ingale K. Development and Validation of Novel UV Methods for Irbesartan and Hydrochlorothiazide Combination. Asian J. Res. Chem. 2010; 3(3): 728-731.

  • El-Bardicy MG, Lotfy HM, El-Sayed MA, and El-Tarras MF. Smart Stability-Indicating Spectrophotometric Methods for Determination of Binary Mixtures Without Prior Separation. J. AOAC Int. 2008; 91(2): 299-310.

  • International Conference on Harmonization (ICH), Q2B: Validation of Analytical Procedures: Methodology, US FDA 1997: Federal Register.


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  • Spectrophotometric Resolution and Quantification of Ternary Co-formulated Mixture of Thioctic acid, Benfotiamine and Cyanocobalamin

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Authors

Maha A. Hegazy
Analytical Chemistry Department, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt
Amr M. Badawey
Analytical Chemistry Department, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt
Maryam A. Bakr
Pharmaceutical Chemistry Department, Future University in Egypt, 90th St., Fifth Settlement, New Cairo, 11835 Cairo, Egypt
Samah S. Abbas
Analytical Chemistry Department, Cairo University, Kasr El-Aini St., 11562 Cairo, Egypt

Abstract


Four spectrophotometric methods were developed and validated for spectral resolution and determination of thioctic acid (THC), benfotiamine (BEN) and cyanocobalamin (CNCo) in their pure form, laboratory prepared mixtures and capsules. Method A, a first derivative method for determination of CNCo, by recording the peak amplitude at 564.0 nm. Method B, is a Ratio difference spectrophotometric one which is applied for determination of THC and BEN, where CNCo has no interference. Method C applied first derivative of ratio spectra where THC and BEN were determined by recording the peak amplitude at 330.8 and 286.8 nm, in order. Method D a Ratio subtraction method that was successfully determines BEN at its λmax without interference of the other co-formulated drugs. Validation according to ICH guidelines was performed. The linearity ranges were 200.00-1800.00, 2.00-30.00 and 10.00-200.00 μg/mL for THC, BEN and CNCo, in a respective order. The methods were found to be accurate, precise and specific.

Keywords


Derivative, Ratio Difference, Thioctic Acid, Benfotiamine, Cyanocobalamin.

References