QUANTITATIVE ANALYSIS OF METFORMIN HYDROCHLORIDE AND DAPAGLIFLOZIN USING HPLC: METHOD VALIDATION AND APPLICATION IN PHARMACEUTICAL PREPARATIONS
Main Article Content
Keywords
Method Validation, Quality Control, Pharmaceutical Preparation
Abstract
This study presents a validated method for the quantitative analysis of dapagliflozin and metformin hydrochloride (MET), two pivotal medications in the management of type 2 diabetes mellitus. High-Performance Liquid Chromatography (HPLC) equipped with a C18 column and a mobile phase comprising acetonitrile and potassium dihydrogen phosphate buffer solution was employed. Method validation encompassed the establishment of linear calibration curves, determination of accuracy, and calculation of limits of detection (LOD) and quantification (LOQ). Excellent linearity, as indicated by regression coefficients of 0.9998 for dapagliflozin and 0.9997 for metformin hydrochloride, underscores the reliability of the analytical approach. Accuracy assessments yielded results within the acceptable range, affirming the precision of the method. Practical application in pharmaceutical quality control laboratories was demonstrated through the analysis of both pure doses and pharmaceutical preparations, highlighting the method's utility in real-world settings. While the study offers a robust methodology, further exploration of potential limitations and method robustness factors would enrich its contribution to the field.
References
2. K. R. Vankalapati, P. Alegete, S. Boodida “Stability Indicating UPLC method Development and Validation for Simultaneous estimation of Metformin Linagliptinin Empagliflozin and in Bulk and Pharmaceutical Dosage Form” Biomed. Chromatog., 30(7),2315-2367(2020).
3. R. G. Alamri, K. Mohsin, A. Ahmad, M.Raish, F. K. Alanazi “Development and validation of bioanalytical UHPLC-UV method for simultaneous analysis of unchanged fenofibrate and its metabolite fenofibricacid in rat plasma” Appl. pharmacokinetics., 25(1), 128-135(2017).
4. S.Donepudi, S.Achanta “Validated HPLC-UV method for simultaneous estimation of linagliptin and empagliflozin in human plasma” Int. J.App. Pharma., 10(3), 56-61 (2018).
5. V. Kommineni, K. P. R. Chowdary, S. M. Prasad “Development of a new stability indicating RP-HPLC method for simultaneous estimation of setagliptine and dapagliflozin and its validation as per ICH guidelines” J. pharm., 4(09), 2920-2932 (2017).
6. R. Maruthi, R. A. K. Tengli “Bio-analytical method development and validation of dichlorvos pesticide by rp-uflc method” J. Pharm. Tech., 13(8), 3725-3728(2020).
7. D. Meira Rafaela, Z. Zielinski Cavalheiro "In vitro dissolution profile of dapagliflozin development, method validation, and analysis of commercial tablets" j. anal. Chem., 1250(4), 234-540(2017).
8. P. Kumar, T. E. G. K. Murthy, M. B. Rao “Development, validation of liquid chromatography-tandem mass spectrometry method for simultaneous determination of rosuvastatin and metformin in human plasma and its application to a pharmacokinetic study” J. Adv. Pharm. Tech., 6(3), 118 (2015).
9. Q. Fang, X. Liu, J. Ding, R. Xu “Soluble epoxide hydrolase inhibition protected against diabetic cardiomyopathy through inducing autophagy and reducing apoptosis relying on Nrf2 upregulation and transcription activation” Oxid Medicine Cell. Longevity., 23(3),570-595(2022).
10. A.Rane, R. N. Nechi, M. Imam, C. R. Zoni “Comparative value of dapagliflozinvsempagliflozin in patients with heart failure and preserved ejection fraction” J. Manag. Care. Spec. Pharmacy., 29(9), 1045-1053 (2023).
11. V.Perkovic, R. Agarwal, P.Fioretto“Management of patients with diabetes and CKD from a Kidney Disease Improving Global Outcome (KDIGO) Controversies Conference” Kidney. Int., 90(6), 1175-1183 (2016).
12. C. K. Cheung, A. Rajasekaran, J. Barratt “An update on the current state of management and clinical trials for nephropathy” J. Clin. Medicine., 10(11), 2493(2021).
13. R. Patel, D.Pritesh “Global development, converging divergence and development studies: A rejoinder” Devel. Change., 50(2), 495-510 (2019).
14. A. A. Gahlan, S. M.Derayea “Square Wave Anodic Voltammetric Determination of Antidiabetic Drug Linagliptin in The Dosage Form and Biological Fluids by Microparticles Copper Pencil Graphite Electrode” J. Chem., 64(6), 3121-3130 (2021).
15. P. Padmaja, S. S. Rane, A. Ajameri “Validation of a simple RP-HPLC method developed for the quantification of meta-cresol in parathyroid hormones formulation” Pharm. Meth., 2(3), 203-208(2016).
16. B.M. Ayoub, R. I. Bagary, E.F. Elkady“Liquid chromatographic determination of alogliptin in bulk and in its pharmaceutical preparation” j. biomed. Sc., 8(3), 215 (2020).
17. S. Sunkara, M.Manian, K.Korey, W. Fowler, A. K. Banga“Evaluation of an activated carbon-based deactivation system for the disposal of highly abused opioid medications” Drug .Dev. Pharmacy., 44(1), 125-134 (2018).
18. . Z.Sohrabi, H. Koohestani, S. Delavari, R. Rezaee “Development and psychometrics of script concordance test (SCT) in midwifery” J. the Islam. Repub. Iran., 32(12), 209-275 (2018).
19. Y. S. Xie, M. Z. Dai, C. X. Zhu,J. Liu, L. J. Zhang “Validation, optimization, and application of the zebrafish developmental toxicity assay for pharmaceuticals under the ICH S5 (R3) guideline” Front. Cell. Devel. Biology., 11(2), 9721130 (2021).
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Zahid Khan
Department of Chemistry, Women University Swabi, Swabi, KPK, Pakistan
Khadim Hussain
Department of Chemistry, Bacha Khan University, Charsadah, KPK, Pakistan
Atya Hassan
Department of Chemistry, Federal Urdu University of Arts Science and Technology, Karachi, Pakistan
Nida Ali
Department of Chemistry, University of Karachi, Karachi, Pakistan
Asad Khan Tanoli
Department of Chemistry, University of Karachi, Karachi, Pakistan
Ghazali Hussain
Department of Chemistry, University of Karachi, Karachi, Pakistan
Muhammad Saadiq
Department of Chemistry, Bacha Khan University, Charsadah, KPK, Pakistan