Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in marketed formulation
Abstract
Simple, precise and accurate UV-Spectrophotometric simultaneous equation method for estimation of dapagliflozin (DAPA) and saxagliptin (SAXA) were developed and validated as per ICH guidelines. This Method involves solving of simultaneous equations based on measurement of absorbance at two wavelengths 222 nm and 276 nm (λmax of SAXA and DAPA) in phosphate buffer pH 6.8. Both the drugs obey the Beer’s law in the concentration ranges 5-25µg/ml. % Recovery for both the drugs were in the range of 98.44-99.05% indicating excellent accuracy. The methods were precise, with a relative standard deviation of less than 2% for both drugs. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercial formulation (QTERN tablets, Astra Zeneca).
Keywords: Dapagliflozin, Saxagliptin, Spectrophotometric analysis, Simultaneous equation method.
DOI
https://doi.org/10.22270/jddt.v9i4-s.3828References
Deacon CF, Holst JJ (2009) Saxagliptin is a new dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Adv Ther 26: 488-499.
Mentlein R, Gallwitz B, Schmidt WE (1993) Dipeptidyl-peptidase IV hydrolyses gastric inhibitory polypeptide, glucagon-like peptide-1(7-36) amide, peptide histidine methionine and is responsible for their degradation in human serum. Eur J Biochem 214: 829-835.
Ahren B, Landin-Olsson M, Jansson PA, Svensson M, Holmes D, et al. (2004) Inhibition of dipeptidyl peptides-4 reduces glycemia, sustains insulin levels and reduces glucagon levels in the type 2 diabetes. J Clin Endocrinol Metab 89: 2078-2084.
Vithoba MG, Krishna RG, Hemke AT (2017) Estimation of dapagliflozin from its tablet formulation by UV-spectrophotometry. Pharm Methods 8: 102-107.
M Sanagapati, DK Lakshmi, NG Reddy, S Sreenivasa, Development and validation of stability indicating RP-HPLC method for determination of dapagliflozin, J Adv Pharm Edu Res. 4(3) (2014) 350-3.
BR Jani, KV Shah, PP Kapupara, Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. J Bioequiv. 1(1) (2015)102.
M Sanagapati, K Dhanalakshmi, NG Reddy, S Sreenivasa, Method Development and Validation of Dapagliflozin in API by RP-HPLC and UV-Spectroscopy. Int J Pharm Sci and drug Res. 6(3) (2014) 250-2.
PC Karuna, E China, MV Basaveswara Rao, Unique UV spectrophotometric method for reckoning of Dapagliflozin in bulk and pharmaceutical dosage forms. J Chem Pharm Res. 7(9) (2015) 45-9.
S Manasa, K Dhanalakshmi, NG Reddy, S Sreenivasa, Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. Int J Pharm Sci Drug Res. 6(3) (2014) 250-2.
DJ Augeri, JA Robl, DA Betebenner, DR Magnin, A Khanna, Discovery and preclinical profile of Saxagliptin (BMS-477118): a highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes. J Med Chem. 48 (2005) 5025-5037.
R. Kalaichelvi, E. Jayachandran, Validated Spectroscopic method for the estimation of Saxagliptinin pure and from tablet formulation. Int J Pharm Pharm Sci. 3 (2011) 179-180.
N. Nyola, G. S. Jeyabalan, Development and validation of UV-VIS spectroscopy method for simultaneous estimation of saxagliptin hydrochloride and metformin hydrochloride in active pharmaceutical ingredient, J Pharm Educ Res. 3, IssueNo. 2, December 2012.
P. Patil Prafulla, Kalkotwar Ramesh.S, V.V Patil, V.B Jadhav, N. Patil .P, A new RP – HPLC Method for derermination of metformin HCl and saxagliptin in tablet dosage form, IJPBS 2(4) (2012) 161-167.
N.V.M.S. Bhagavanji, Development and validation of stability indicating LC method for the simultaneous estimation of metformin and saxagliptin in combined dosage form, VSRD International Journal of Technical &Non-Technical Research, Vol. 3 No. 11 November2012.
S. Inturi, R. Inturi, I.K. Tagaram, Validated novel LC determination of saxagliptin in pure bulk and pharmaceutical dosage forms, IJPRD, 2011;Vol 3(8): November 2011 (45 - 52).
El-Bagary, I. Ramzia. Elkady, F. Ehab, Ayoub, M. Bassam, Spectrophotometric methods based on charge transfer complexation reactions for the determination of saxagliptin in bulk and pharmaceutical preparation. International Journal of Biomedical Science. 8 (2012) 204-208.
X. Xu, R. Demers, H. Gu, L. Christopher, H. Su, L. Cojocaru. Liquid chromatography and tandem mass spectrometry method for the quantitative determination of saxagliptin and its major pharmacologically active 5-monohydroxy metabolite in human plasma: method validation and overcoming specific and non-specific binding at low concentrations; Journal of Chromatography B, 889 (2012) 77-86.
R.P. Cumar, M. Vasudevan, A. Deecaraman, Validated RP-HPLC method for simultaneous estimation of metformin and saxagliptin in tablets. Rasayan Journal of Chemistry. 5 (2012) 137-114.4.
P. Kumar, R. Vasudevan, Deecaraman, A Validated RP-HPLC Method for Simultaneous Estimation of Metformin and Saxagliptin in Tablets. Rasayan Journal Chemistry. 5 (2012) 137-141.
P. S. Rao, D. Rama Chandran, K. Murali, S. Srinivasu, Stability Indicating Isocratic Reverse Phase HPLC Method with PDA Detector for the Estimation of Saxagliptin in Bulk Drugs and in Its Formulation. International Journal of Pharma Sciences. 3 (2013) 333-342.
P.P Prakash, R.S. Kalkotwar, V.P. Vikas, B.J. Vijay, P.P. Nilesh, A new RPHPLC method for determination of Metformin HCl and Saxagliptin in tablet dosage form. International Journal of Pharmacy and Biological Sciences. 2 (2012) 161-167.
M. Sarat, P. Murali Krishna, C. Rambabu, RP-HPLC method for simultaneous estimation of saxagliptin and pioglitazone in tablets. International Research Journal of Pharmacy. 3 (2012) 399-402.
M.M. Abdul -Azim, E.F. Elkady, M.A. Fouad, Development and validation of a reversed-phase column liquid chromatographic method for simultaneous determination of two novel gliptins in their binary mixtures with metformin. European Journal of Chemistry. 3 (2012) 152-155.
Beckett AH, Stanlake JB. Practical Pharmaceutical Chemistry, fourth ed., part 2. CBS Publishers and Distributors, New Delhi 1997.
ICH Guidelines: Validation of Analytical Procedures: Text and Methodology Q2 (B), 2005.
Laxman R, Acharya A, Jain V, Bhardwaj S, Jain D. Development and validation of RP-HPLC and ultraviolet spectrophotometric methods simultaneous determination of spironolactone and torsemide in pharmaceutical dosage form. Int J Res Ayurveda Pharm 2010; 1(2):459-467
Published


How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).