Volume : 12, Issue : 08, August- 2025

Title:

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

Authors :

Kavana D. C*, Naveen Kumar G.S. Sowmya H.G

Abstract :

The quantification of Dapagliflozin in pharmaceutical dosage forms and bulk medication has been accomplished through the development and validation of a new, precise, and effective Area under curve derivative UV spectroscopic approach. The absorbance of Dapagliflozin reaches its maximum at 224 nm in acetonitrile and ethanol (70:30), and the Area under curve in absorption spectra measured between wavelength range in 219nm and 229nm , its concentration falls between 3 and 18 µg/mL according to Beer’s Law. A correlation value (R2) of 0.999 demonstrated the method’s great linearity, demonstrating high consistency and dependability throughout the spectrum under study. While the limits of detection (LOD) and quantitation (LOQ) were determined to be 0.0707 µg/mL and 0.2142µg/mL, respectively, recovery rates ranged from 98.15% to 100.09%. Additionally, the method’s relative standard deviation (%RSD) values were less than 2%, indicating exceptional accuracy.The ICH recommendations were followed in evaluating the following validation parameters: linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ. For regular analysis of Dapagliflozin in different pharmaceutical formulations, this verified spectroscopic methodology proved to be a reliable and repeatable method.
KEYWORDS: Dapagliflozin, Area under curve [AUC], Validation, Pharmaceutical formulation.

Cite This Article:

Please cite this article in press Kavana D. C et al ., Development And Validation Of Uv Spectroscopic Method For The Estimation Of Dapagliflozin In Bulk And Tablet Dosage Form., Indo Am. J. P. Sci, 2025; 12(08).

Number of Downloads : 10

References:

1. Al-Arjani RA. Development and Validation of a New Combination: Dapagliflozin, Pioglitazone and Metformin Simultaneously in Tablets Dosage Form by HPLC . Master’s thesis, University of Petra .Aug 2021:9-24.
2. Padmaja BR, Sivagami B, Chandrasekar R, Babu MN. A highly validated RP-HPLC method development for the simultaneous estimation of dapagliflozin and saxagliptin in tablet dosage forms. Int J Pharm Sci Drug Res. 2018 sep-oct;10(5):372-8.
3. Mante GV, Gupta KR, Hemke AT. Estimation of dapagliflozin from its tablet formulation by UV-spectrophotometry. Pharm Methods. 2017 Jul 1;8(2):102-7.
4. V.B. Tambe, P.S. Tajane, R. K. Godge.Analytical method Development and Validation of Dapagliflozin by UV-spectroscopy. IJFANS Intl J of Food and Nutritional Sci.2022;11(11):709-716.
5. Yadav M, Chauhan R, Singh R, Tiwari N. UV-Spectrophotometric Approach for Concurrent Assessment of Sitagliptin and Dapagliflozin.Afr.J.Bio.Sc. 2024 Apr 22;6(9):1024-1032.
6. Suthar AM, Prajapati LM, Joshi AK, Patel JR, Kharodiya ML. Estimation of Saxagliptin hydrochloride and Dapagliflozin propendiol monohydrate in combined dosage form. J. of Innv in Appl Pharm Sci (JIAPS). 2018 Jun 30;3(2):01-7.
7. Patel A, Omray DL, Soni P. Method development for simultaneous estimation of Dapagliflozin and saxagliptin in fixed-dose combination and validation on UV spectroscopy. J Pharm. 2020;9(3):2536-43.
8. Minal H, Sameer L, Valmik G, Vitthal C, Khomne A. Ultraviolet-spectrophotometric method for simultaneous estimation of Dapagliflozin propanediol and Metformin hydrochloride. Intl Res J of Pharm. 2019;10(4):90-4.
9. Patel M, Vyas N, Shah H, Shah U, Patel A, Chokshi A. Analytical methods for simultaneous estimation of SGLT2 inhibitor and DPP-4 inhibitor in their combination for treatment of type 2 diabetes mellitus. Lett Appl NanoBioScience. 2020;10(1):1799-815.
10. Mahabole S, Gajeli G, Kalshetti M. RP-HPLC and UV Spectroscopic Method Development and Validation for Estimation of Dapagliflozin in Bulk and Pharmaceutical Dosage Form. Research Sqare. 2024 jun12:2-15.
11. Borse LB, Wagh MS, Borse SL, Ahire SP, Vaishnav IS, Naphade VD, Gulecha VS. RP- HPLC Method Development And Validation For Estimation Of Dapagliflozin In Tablet Formulation. J of Pharm Negative Results. 2022 Oct 15;13(5):364-72.
12. Mante GV, Hemke AT, Umekar MJ. RP-HPLC method for estimation of dapagliflozin from its tablet. Intl J of Chem Tech Res. 2018;11(01):242-8.
13. Gaikwad AV, Gawade AS, Hupparage Vrushabh B, Mantry S, Kale A, Kale J. Method Development and Validation of Dapagliflozin by RP-HPLC. Jl of Pharm Negative Results. 2022 Dec 31;13(6):4316-35.
14. Sree VN, Bhavyasri DK, Sumakanth DM, Swethasri R. Estimation of Dapagliflozin in Pure and Marketed Formulation by Validated Reverse Phase-High Performance Liquid Chromatographic Method.(2020). Int. J. Life Sci. Pharma Res.;10(4):P70-84.
15. Sravanthi S, Zarin N, Shruthi B, Krishna DR, Manjeera A. A New Analytical MethodDevelopment and Validation for the Estimation of Dapagliflozin by Using Reverse Phase- High Performance Liquid Chromatography.Intl J of adv res in medical pharm sci:jul 2021:6(4):13-20
16. Debata J, Kumar S, Jha SK, Khan A. A New RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage form. Int J Drug Dev Res. 2017;9(2):48-51.
17. Pal N, Mahtab T, Reddy PP, Rao AS.A new HPLC method development and validation for the determination of dapagliflozin in tablet dosage form.World J of pharma res.2019:8(9):1156-1165.
18. Urooj A, Sundar PS, Vasanthi R, Raja MA, Dutt KR, Rao KN, Ramana H. Development and validation of RP-HPLC method for simultaneous estimation of dapagliflozin and metformin in bulk and in synthetic mixture. World J Pharm Pharm Sci. 2017 May 20;6(7):2139-50.
19. Rao BR, Rao VV, Venkateswarlu BS. RP-HPLC method for simultaneous estimation of dapagliflozin and saxagliptin in bulk samples. J of Pharm Sci and Res. 2019;11(1):254-7.
20. Bhavyasri K, Surekha T, Begum S, Sumakanth M. RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation. Archives of Pharmacy Practice. 2021;12(4-2021):106-10.
21. Kladi E, Zerva M, Dotsikas Y. A novel HPLC method for the simultaneous determination of empagliflozin and dapagliflozin: Development, validation, robustness testing and greenness assessment. Archives of Pharmacy. 2024 Apr 28;74(Notebook 2):267-80.
22. Suma BV, Deveswaran R, Premnath SH. A new high-performance thin layer chromatographic method development and validation of dapagliflozin in bulk and tablet dosage form. Int J Pharm Pharm Sci. 2019 Aug 1;11(8):58-63.
23. Madhavi S, Rani AP. Development and validation of a method for simultaneous determination of dapagliflozin and saxagliptin in a formulation by RP-UPLC. World J Pharma Res. 2017 Aug 11;6(12):904-16.
24. ICH, Q2A text on validation of analytical procedures; 1994.
25. ICH, Q2B validation of analytical methodology; 1996.
26. ICH, Q2 (R1) validation of analytical procedures: text and methodology; 2005.