Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets

References

• Powers, A.C. Diabetes Mellitus. In Harrison’s Principles of Internal Medicine, 16th ed.; Braunwald, E. Eds.; McGraw-Hill Companies Inc.: New York, 2005, pp 2152–2153.
   Google Scholar
• Radziuk, J.; Pye, S. The Metabolic Syndrome: Epidemiology, Clinical Treatment, and Underlying Mechanisms. In Contemporary Endocrinology, Hansen, B. C.; Bray G. A., Eds.; Humana Press: Totowa, NJ, 2008, pp. 343–371.
   Google Scholar
• Ogurtsova, K.; da Rocha Fernandes, J.D.; Huang, Y.; Linnenkamp, U.; Guariguata, L.; Cho, N.H., Cavan, D., Shaw, J.E.; Makaroff, L.E. IDF Diabetes Atlas: Global Estimates for the Prevalence of Diabetes for 2015 and 2040. Diabetes Res. Clin. Pract. 2017, 128, 40–50. DOI: 10.1016/j.diabres.2017.03.024.
   PubMed Web of Science ®Google Scholar
• Shaw, J.E.; Sicree, R.A.; Zimmet, P.Z.; Global Estimates of the Prevalence of Diabetes for 2010 and 2030. Diabetes Res. Clin. Pract. 2010, 87(1), 4–14. DOI: 10.1016/j.diabres.2009.10.007.
   PubMed Web of Science ®Google Scholar
• Goldman-Levine, J.D. Combination Therapy When Metformin Is not an Option for Type 2 Diabetes. Ann. Pharmacother. 2015, 49(6), 688–699. DOI: 10.1177/1060028015572653.
   PubMed Web of Science ®Google Scholar
• Lavernia, F; Adkins, S.E.; Shubrook, J.H. Use of Oral Combination Therapy for type 2 Diabetes in Primary Care: Meeting Individualized Patient Goals. Postgrad. Med. 2015, 127(8), 808–817. DOI: 10.1080/00325481.2015.1085293.
   PubMed Web of Science ®Google Scholar
• Goodarzi, M.O.; Bryer-Ash, M. Metformin Revisited: Re-evaluation of Its Properties and Role in the Pharmacopoeia of Modern Antidiabetic Agents. Diabetes Obes. Metab. 2005, 7(6), 654–665. DOI: 10.1111/j.1463-1326.2004.00448.x.
   PubMed Web of Science ®Google Scholar
• Consoli, A.; Gomis, R.; Halimi, S.; Home, P.D.; Mehnert, H.; Strojek, K.; Van Gaal, L. F. Initiating Oral Glucose-Lowering Therapy with Metformin in Type 2 Diabetic Patients: an Evidence-Based Strategy to Reduce the Burden of Late-Developing Diabetes Complications. Diabetes Metab. 2004, 30, 509–516. DOI: 10.1016/S1262-3636(07)70148-9.
   PubMed Web of Science ®Google Scholar
• Hundal, R. S.; Krssak, M.; Dufour, S.; Laurent, D.; Lebon, V.; Chandramouli, V.; Inzucchi, S. E.; Schumann, W. C.; Petersen, K. F.; Landau, B. R.; Shulman, G. I. Mechanism by Which Metformin Reduces Glucose Production in Type 2 Diabetes. Diabetes 2000, 49(12), 2063–2069.
   PubMed Web of Science ®Google Scholar
• Rena, G.; Pearson, E.R.; Sakamoto, K. Molecular Mechanism of Action of Metformin: Old or New Insights? Diabetologia. 2013, 56(9), 1898–1906. DOI: 10.1007/s00125-013-2991-0.
   PubMed Web of Science ®Google Scholar
• Karagiannis, T.; Paschos, P.; Paletas, K.; Matthews, D.R.; Tsapas, A. Dipeptidyl Peptidase-4 Inhibitors for Treatment of Type 2 Diabetes Mellitus in the Clinical Setting: Systematic Review and Meta-Analysis. BMJ. 2012, 344, e1369. DOI: 10.1136/bmj.e1369.
   PubMed Web of Science ®Google Scholar
• Migoya, E.M.; Bergeron, R.; Miller, J.L.; Snyder, R.N.; Tanen, M.; Hilliard, D.; Weiss, B.; Larson, P.; Gutierrez, M.; Jiang, G.; Liu, F.; Pryor, K.A.; Yao, J.; Zhu, L.; Holst, J.J.; Deacon, C.; Herman, G.; Thornberry, N., Amatruda, J.; Williams-Herman, D., Wagner, J.A.; SinhaRoy, R. Dipeptidyl Peptidase-4 Inhibitors Administered in Combination with Metformin Result in an Additive Increase in the Plasma Concentration of Active GLP-1. Clin. Pharmacol. Ther. 2010, 88(6), 801–808. DOI: 10.1038/clpt.2010.184.
   PubMed Web of Science ®Google Scholar
• Jadzinsky, M.; Pfützner, A.; Paz-Pacheco, E.; Xu, Z.; Allen, E.; Chen, R. Saxagliptin Given in Combination with Metformin as Initial Therapy Improves Glycaemic Control in Patients with Type 2 Diabetes Compared with Either Monotherapy: A Randomized Controlled Trial. Diabetes Obes. Metab. 2009, 11(6), 611–622. DOI: 10.1111/j.1463-1326.2009.01056.x.
   PubMed Web of Science ®Google Scholar
• van Baar, M.J.B.; van Ruiten, C.C.; Muskiet, M.H.A.; van Bloemendaal, L.; IJzerman, R.G., van Raalte, D.H. SGLT2 Inhibitors in Combination Therapy: From Mechanisms to Clinical Considerations in type 2 Diabetes Management. Diabetes Care. 2018, 41(8), 1543–1556. DOI: 10.2337/dc18-0588.
   PubMed Web of Science ®Google Scholar
• Khomitskaya, Y.; Tikhonova, N.; Gudkov, K.; Erofeeva, S., Holmes, V.; Dayton, B., Davies, N.; Boulton, D.W.; Tang, W. Bioequivalence of Dapagliflozin/Metformin Extended-Release Fixed-Combination Drug Product and Single-Component Dapagliflozin and Metformin Extended-Release Tablets in Healthy Russian Subjects. Clin. Ther. 2018, 40(4), 550–561. DOI: 10.1016/j.clinthera.2018.02.006.
   PubMed Web of Science ®Google Scholar
• Lokhandwala, T.; Smith, N.; Sternhufvud, C.; Sörstadius, E., Lee, W.C.; Mukherjee, J. A Retrospective Study of Persistence, Adherence, and Health Economic Outcomes of Fixed-Dose Combination vs. Loose-Dose Combination of Oral Anti-Diabetes Drugs. J. Med. Econ. 2016, 19(3), 203–212. DOI: 10.3111/13696998.2015.1109518.
   PubMed Web of Science ®Google Scholar
• Schernthaner, G. Fixed-Dose Combination Therapies in the Management of Hyperglycaemia in Type 2 Diabetes: An Opportunity to Improve Adherence and Patient Care. Diabet. Med. 2010, 27(7), 739–743. DOI: 10.1111/j.1464-5491.2010.03000.x.
   PubMed Web of Science ®Google Scholar
• Cholke, P.; Shirsath, M.; Temak, Y.; Kagde, A.; Lagad, R. Development and Validation of UV-Visible Spectroscopy Method for Simultaneous Estimation of Saxagliptin Hydrochloride and Metformin Hydrochloride in Tablet Dosage Form. Int. J. Res. Pharm. Pharmaceut. Sci. 2018, 3(4), 31–34.
   Google Scholar
• Jani, B.R.; Shah, K.V.; Kapupara, P.P. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. Int. J. Res. Develop. Pharm. Life Sci. 2015, 4(3), 1569–1576.
   Google Scholar
• Jani, B.R.; Shah, K.V.; Kapupara, P.P. Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. J. Bioequiv. 2015, 1(1), 102.
   Google Scholar
• Suthar, A.M.; Prajapati, L.M.; Joshi, A.K.; Patel, J.R.; Kharodiya, M.L.; Prajapati, L.M. Estimation of Saxagliptin Hydrochloride and Dapagliflozin Propendiol Monohydrate in Combined Dosage Form. JIAPS 2018, 3(2), 01–07.
   Google Scholar
• Parmar, S.H.; Luhar, S.V.; Narkhede, S.B. Development and Validation of UV-Spectroscopic First Derivative and High Performance Thin Layer Chromatography Analytical Methods for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Saxagliptin Hydrochloride in Synthetic Mixture. EJBPS, 2018, 5(5), 668–684.
   Google Scholar
• El-Kimary, E.I.; Hamdy, D.A.; Mourad, S.S.; Barary, M.A. HPTLC Determination of Three Gliptins in Binary Mixtures with Metformin. J. Chromatogr. Sci. 2016, 54(1), 79–87. DOI: 10.1093/chromsci/bmv106.
   PubMed Web of Science ®Google Scholar
• Merey, H.A.; Ramadan, N.K.; Diab, S.S.; Moustafa, A.A. Chromatographic Methods for the Simultaneous Determination of Binary Mixture of Saxagliptin HCl and Metformin HCl. Bull. Fac. Pharm. Cairo Univ. 2018, 55(2), 311–317. DOI: 10.1016/j.bfopcu.2017.04.002.
   Google Scholar
• Patel, K.J.; Chaudhary, A.B.; Bhadani, S.M.; Raval, R.J. Stability Indicating RP-HPLC Method Development and Validation for Estimation of Dapagliflozin and Metformin HCl. WJPPS., 2017, 6(9), 796–809. DOI: 10.20959/wjpps20179-9638.
   Google Scholar
• Patel, P.D.; Pandya, S.S. Validated RP – HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin Hydrochloride in Tablet Dosage Form. IJPRS 2018, 7(1), 9–15 DOI: 10.31638/IJPRS.V7.I1.00006.
   Google Scholar
• Abdelrahman, A.E.; Maher, H.M.; Alzoman, N.Z. HPTLC Method for the Determination of Metformin Hydrochloride, Saxagliptin Hydrochloride, and Dapagliflozin in Pharmaceuticals. CAC 2019, 15, 1. DOI: 10.2174/1573407215666190131123029.
   Google Scholar
• Hamdan, I.I.; Jaberb, A.K.B.; Abushoff, A.M. Development and Validation of a Stability Indicating Capillary Electrophoresis Method for the Determination of Metformin Hydrochloride in Tablets. J. Pharm. Biomed. Anal. 2010, 53, 1254–1257. DOI: 10.1016/j.jpba.2010.03.017.
   PubMed Web of Science ®Google Scholar
• Strugaru, A.M.; Mircea, C.; Agoroaei, L.; Botnariu, G.; Grigoriu, I.C.; Marti, T.D.; Butnaru, E. Quantitative Determination of Metformin by Capillary Electrophoresis with UV Detection. Rev. Chim. (Bucharest) 2015, 66(9), 1448–1451.
   Web of Science ®Google Scholar
• Salim, M., El-Enany, N.; Belal, F.; Walash, M.; Patonay, G. Simultaneous Determination of Sitagliptin and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis and its Application to Human Plasma Analysis. Anal. Chem. Insights 2012, 7, 31–46.
   PubMedGoogle Scholar
• Attimarad, M. Multivariate Optimization of a Capillary Zone Electrophoresis Assay Method for Simultaneous Quantification of Metformin and Vildagliptin from a Formulation. J. Liq. Chromatogr. Rel. Techol. 2016, 39(8), 401–407. DOI: 10.1080/10826076.2016.1169426.
   Web of Science ®Google Scholar
• Barden, A.T.; Piccoli, B.L.; Volpato, N.M.; Steppe, M. A Simultaneous Assay Method Using Capillary Zone Electrophoresis for a Fixed Dose Combination of Vildagliptin and Metformin Hydrochloride in Coated Tablets. Anal. Methods, 2013, 5, 5701–5708.
   Web of Science ®Google Scholar
• Wei, S.Y.; Yeh, H.H.; Liao, F.F.; Chen, S.H. CE with Direct Sample Injection for the Determination of Metformin in Plasma for Type 2 Diabetic Mellitus: An Adequate Alternative to HPLC. J. Sep. Sci. 2009, 32, 413–421. DOI: 10.1002/jssc.200800463.
   PubMed Web of Science ®Google Scholar
• Doomkaew, A.; Prutthiwanasan, B.; Suntornsuk, L. Simultaneous Analysis of Metformin and Cyanoguanidine by Capillary Zone Electrophoresis and its Application in a Stability Study. J. Sep. Sci. 2014, 37, 1687–1693. DOI: 10.1002/jssc.201400310.
   PubMed Web of Science ®Google Scholar
• Yardımcı, C; Özaltın, N. Method Development and Validation for the Simultaneous Determination of Rosiglitazone and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis. Anal. Chim. Acta 2005, 549, 88–95. DOI: 10.1016/j.aca.2005.06.014.
   Web of Science ®Google Scholar
• Tůma, P. Large Volume Sample Stacking for Rapid and Sensitive Determination of Antidiabetic Drug Metformin in Human Urine and Serum by Capillary Electrophoresis with Contactless Conductivity Detection. J. Chromatogr. A 2014, 1345, 207–211. DOI: 10.1016/j.chroma.2014.04.016.
   PubMed Web of Science ®Google Scholar
• Orlandini, S.; Pasquini, B; Gotti, B.P.R.; Giuffrida, A.; Paternostro, F.; Furlanetto, S. Analytical Quality by Design in the Development of a Cyclodextrin-Modified Capillary Electrophoresis Method for the Assay of Metformin and its Related Substances. Electrophoresis 2014, 35, 2538–2545. DOI: 10.1002/elps.201400173.
   PubMed Web of Science ®Google Scholar
• Deng, B.; Shi, A.; Kang, Y.; Li, L. Determination of Metformin Hydrochloride Using Precolumn Derivatization with Acetaldehyde and Capillary Electrophoresis Coupled with Electrochemiluminescence. Luminescence 2011, 26, 592–597. DOI: 10.1002/bio.1276.
   PubMed Web of Science ®Google Scholar
• Kapnissi-Christodoulou, C.P. Method Development by Use of Capillary Electrophoresis and Applications in Pharmaceutical, Biological and Natural Samples. In Electrophoresis; Ghowsi, K, Eds.; InTechOpen: Croatia, 2012. DOI: 10.5772/45834.
   Google Scholar
• ICH. Q2(R1): Validation of Analytical Procedure: Text and Methodology [Internet]. ICH Guideline. 2005 [cited 14 April 2018]. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf
   Google Scholar
• Miller, J. N.; Miller, J. C. Statistics and Chemometrics for Analytical Chemistry, 5th ed. Pearson Prentice Hall: Harlow, England; New York, 2005.
   Google Scholar