Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review
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Saxagliptin, Sitagliptin, dipeptidyl peptidase-4 inhibitor, RP-HPLC, ICH guidelines
Abstract
The study's goal was to develop a plain, quick, and responsive RP-HPLC method for determining the concentrations of Saxagliptin and Sitagliptin in pharmaceutical bulk dosage form (bulk powders). Isocratic elution with Cosmosil C18 (250nm 4.6nm, 5m particle size) and UV detection at 212nm for Saxagliptin and Develosil ODS HG-5 RP-C18 (15cm 4.6mm, 5m particle size) and UV detection at 255nm for Sitagliptin were used in this chromatographic process. Methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: These protocols have been put through their paces in accordance with ICH guidelines. The normal curves for Saxagliptin and Sitagliptin were observed to have a linear relationship across the analytical ranges of 10-50 g/ml and 30-70 g/ml, respectively. The accuracy, precision, limit of identification, the limit of quantification, and robustness of the system were all calculated. Various analytical methods such as UPLC (Ultra performance liquid chromatography), UV spectroscopy, LC-UV methods have performed to the quantitative determination of Saxagliptin and Sitagliptin drugs.
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References
Bays, H. 2013. Sodium Glucose Co-transporter Type 2 (SGLT2) Inhibitors: Targeting the Kidney to Improve Glycemic Control in Diabetes Mellitus. Diabetes Therapy, 4(2):195–220.
Cholke, P., Shirsath, M. 2018. Development and validation of UV-Visible spectroscopic method for simultaneous estimation of saxagliptin hydrochloride and Metformin hydrochloride in tablet dosage form. International Journal of research in pharmacy and pharmaceutical sciences, 3(4):31–34.
Deepan, T., Dhanaraju, M. D. 2018. Stability indicating HPLC method for the simultaneous determination of dapagliflozin and saxagliptin in bulk and tablet dosage form. Current Issues in Pharmacy and Medical Sciences, 31(1):39–43.
Deepthi, G. 2019. RP-HPLC method development and validation for the Determination of Sitagliptin in bulk and pharmaceutical dosage form. International journal of advanced research in medical and pharmaceutical science, 4(10):19–27.
Kalra, S., Ghosh, S., Aamir, A. H., Ahmed, M. T., Amin, M. F., Bajaj, S. 2017. Safe and pragmatic use of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes mellitus: South Asian Federation of Endocrine Societies consensus statement. Indian J Endocrinol Metab, 21(1):210–230.
Lokhande, P. 2020. Development and validation of HPLC method for the analysis of Saxagliptin in bulk drug. International journal of trend in scientific research and development, 4(2):37–41.
Malleswararao, C. S. N. 2012. Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method. Scientia Pharmaceutica, 80(1):139– 152.
Nikam, N., Maru, A., Jadhav, A., Malpure, P. 2019. Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines. International Journal of Trend in Scientific Research and Development, 3(3):415– 419.
Patel, P.D., Pandya, S. S. 2018. Validated RP – HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin Hydrochloride in Tablet Dosage Form. International Journal for Pharmaceutical Research Scholars, 7(1):9–15.
Pathade, P., Imram, M. 2011. Development and validation of stability indicating UV Spectroscopy method for estimation of Sitagliptin phosphate in bulk and tablet dosage form. Journal of Pharmacy Research, 4(3):871–873.
Prasad, P. B. N., Satyanaryana, K., Krishnamohan, G. 2015. Development and Validation of a Method for Simultaneous Determination of Metformin and Saxagliptin in a Formulation by RP-HPLC. American Journal of Analytical Chemistry, 6(11):841– 850.
Rao, A.S.S., Vijayalakshmi, 2020. Analytical method development and validation of antidiabetic drugs (Dapagliflozin and Saxagliptin) by RP-UPLC method. Journal of the University of Shanghai of science and technology, 22(11):456– 464.
Shabir, G. A. 2003. Validation of HPLC Chromatography Methods for Pharmaceutical Analysis. Understanding the Differences and Similarities between Validation Requirements of FDA, the US Pharmacopeia and the ICH. J. Chromatogr, 987(1-2):57– 66.
Singh, N., Bansal, P., Maithani, M., Chauhan, Y. 2018. Development and validation of a stability- indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination. New Journal of Chemistry, 42(4):2459–2466.
Sivagami, B., Padmaja, B. R., Babu, M. N. 2018. A Highly Validated RP-HPLC Method Development for the Simultaneous Estimation of Dapagliflozin and Saxagliptin in Tablet Dosage Forms. International Journal of Pharmaceutical Sciences and Drug Research, 10(5):372–378.
Williard, H. H., Merit, L. L., Dean, F. A., Settle, F. A. 2002. Instrumental methods of analysis, seventh edition. New Delhi. C.B.S. Publishers.
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