Archive \ Volume.12 2021 Issue 4

RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation

, , ,

Abstract

The given RP-HPLC technique was found to be clear-cut, specific, exact, and economical for estimation of Dapagliflozin and Metformin HCl in bulk and tablet dosage form. Stationary phase Phenomenex C18 250mm x 4.6 mm were utilized as chromatographic conditions. Water: Methanol in the ratio of 50:50 was used as fluid phase. The flow rate was maintained at 5 1.0ml/min, wave length of detection was 230 nm and diluent was water all maintained at a 300C column temperature. As an optimized procedure, the conditions were finalized. By injecting the standard six times, apt system factors were studied and the outcomes were considerably below the acceptance criteria. Metformin HCl linearity was found to be 2-7 ppm and Dapagliflozin linearity was found to be 60-210 ppm with r2=0.999. For Dapagliflozin and Metformin HCl, precision value was found to be 0.8214% and 0.6342% respectively. For Dapagliflozin, LOD and LOQ values were found to be 345000 ppb and 415000 ppb respectively and for Metformin HCl LOD and LOQ values were found to be 263000 and 324000 ppb respectively. Assessment of the formulated market was carried out by using above method and percentage of Dapagliflozin and Metformin HCl was found to be 99.73 % and 99.85 % respectively.



How to cite:
Vancouver
Bhavyasri K, Surekha T, Begum S, Sumakanth M. RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation. Arch Pharm Pract. 2021;12(4):106-10. https://doi.org/10.51847/Czxl0wYrYr
APA
Bhavyasri, K., Surekha, T., Begum, S., & Sumakanth, M. (2021). RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation. Archives of Pharmacy Practice, 12(4), 106-110. https://doi.org/10.51847/Czxl0wYrYr

Download Citation
References

1.        Dezani TM, Dezani AB, Serra CH. Development and validation of RP-HPLC method for simultaneous determination of lamivudine, stavudine, and zidovudine in perfusate samples: Application to the Single-Pass Intestinal Perfusion (SPIP) studies. Braz J Pharm Sci. 2021;57:e19073.

2.        Chaowuttikul C, Palanuvej C, Ruangrungsi N. Quantification of chlorogenic acid, rosmarinic acid, and caffeic acid contents in selected Thai medicinal plants using RP-HPLC-DAD. Braz J Pharm Sci. 2020;56:e17547.

3.        Lee MG, Choi YH, Lee I. Effects of diabetes mellitus induced by alloxan on the pharmacokinetics of metformin in rats: restoration of pharmacokinetic parameters to the control state by insulin treatment. J Pharm Pharm Sci. 2008;11(1):88-103.

4.        Martínez-Flórez A, Galizzi M, Izquierdo L, Bustamante JM, Rodriguez A, Rodriguez F, et al. Repurposing bioenergetic modulators against protozoan parasites responsible for tropical diseases. Int J Parasitol Drugs Drug Resist. 2020;14:17-27.

5.        Brocks D, Gabr RQ, Padwal RS. Determination of metformin in human plasma and urine by high-performance liquid chromatography using small sample volume and conventional octadecyl silane column. J Pharm Pharm Sci. 2010;13(4):486-94.

6.        Salem HF, Nafady MM, Ali AA, Khalil NM, Elsisi AA. Evaluation of Metformin Hydrochloride Tailoring Bilosomes as an Effective Transdermal Nanocarrier. Int J Nanomed. 2022;17:1185-201.

7.        Urooj A, Sundar PS, Vasanthi R, Raja MA, Dutt KR, Rao KN, et al. 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;6(7):2139-50.

8.        Patel KJ, Chaudhary AB, Bhadani SM, Raval RJ. Stability indicating RP-HPLC method development and validation for estimation of dapagliflozin and metformin HCL. World J Pharm Pharm Sci. 2017;6(9):796-809.

9.        Deepan T, Rao MB, Dhanaraju MD. Development of validated stability indicating assay method for simultaneous estimation of metformin and dapagliflozin by RP-HPLC. Eur J Appl Sci. 2017;9(4):189-99.

10.      Olaya MD, Vergel NE, López JL, Viña D, Guerrero MF. Quantification of chlorogenic acid, rosmarinic acid, and caffeic acid contents in selected Thai medicinal plants using RP-HPLC-DAD. Braz J Pharm Sci. 2020;56:e17609.

11.      Jani BR, Shah KV, Kapupara PP. 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.

12.      Parmar SH, Luhar SV, Narkhede SB. 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. Eur J Biomed Pharm Sci. 2018;5:668-84.

13.      Sanagapati M, Lakshmi DK, Reddy NG, Sreenivasa S. Development and validation of stability-indicating RP-HPLC method for determination of dapagliflozin. J Adv Pharm Educ Res. 2014;4(3).

14.      Mishra K, Soni H, Nayak G, Patel SS, Singhai AK. Method development and validation of metformin hydrochloride in tablet dosage form. J Chem. 2011;8(3):1309-13.

15.      Lambers Heerspink HJ, De Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose‐regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes ObesMetab. 2013;15(9):853-62.

16.      Venkataraman S, Manasa M. Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products-a review. Drug Invent Today. 2018;10(2).

17.      Naveed S, Shafiq A, Khan M, Jamal M, Zafar H, Hashim H, et al. Degradation study of available brands of metformin in Karachi using UV spectrophotometer. J Diabetes Metab. 2014;5(328):2.

18.      Aubry AF, Gu H, Magnier R, Morgan L, Xu X, Tirmenstein M, et al. Validated LC–MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis. 2010;2(12):2001-9.

19.      Bhoomaiah B, Shree AJ. Development and validation of RP-HPLC method for simultaneous determination of metformin and miglitol in bulk and pharmaceutical formulation. Int J Pharm Pharm Sci. 2014;6(6):135-41.

20.      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.

21.      Maher HM, Abdelrahman AE, Alzoman NZ, Aljohar HI. Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets. J Liq Chromatogr Relat Technol. 2019;42(5-6):161-71.

22.      Hassib ST, Taha EA, Elkady EF, Barakat GH. Validated liquid chromatographic method for the determination of (canagliflozin, dapagliflozin or empagliflozin) and metformin in the presence of (1-cyanoguanidine). J Chromatogr Sci. 2019;57(8):697-707.

23.      Manoharan G, Ismaiel AM, Ahmed ZM. Stability-indicating RP-HPLC method development for simultaneous determination and estimation of dapagliflozin in raw and tablet formulation. Chem Res J. 2018;3(2):159-64.

24.      International conference on Harmonization guidance for Industry in: Q2B, Text on Validation of Analytical methods, Switzerland, IFPMIA, 1996. 1-8.

25.      Kommineni V, Chowdary KPR, Prasad SVUM. Development of a new stability indicating RP-HPLC method for simultaneous estimation of Saxagliptin and Dapagliflozin and its validation as per ICH guidelines. Indo Am J Pharm Sci. 2017;4(09):2920-32.

26.      Araujo ED, Rosa AM, Amaral MS, Sversut RA, Baroni AC, Oliveira LC, et al. Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolone in combination with a non-steroidal anti-inflammatory drug in pharmaceutical formulation. Braz J Pharm Sci. 2020;56:e17758.

27.      Goring S, Hawkins N, Wygant G, Roudaut M, Townsend R, Wood I, et al. Dapagliflozin compared with other oral anti‐diabetes treatments when added to metformin monotherapy: a systematic review and network meta‐analysis. Diabetes Obes Metab. 2014;16(5):433-42.

28.      Zhang M, Zhang L, Wu B, Song H, An Z, Li S. Dapagliflozin treatment for type 2 diabetes: a systematic review and meta‐analysis of randomized controlled trials. Diabetes/Metab Res Rev. 2014;30(3):204-21.

29.      Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015;38(3):376-83.

30.      Khalil GA, Salama I, Gomaa MS, Helal MA. Validated RP-HPLC method for Simultaneous determination of Canagliflozin, Dapagliflozin, Empagliflozin and Metformin. Int J Pharm Chem Biol Sci. 2018;8(1).

31.      Patel ND, Shah DB, Maheshwari DG. A Review on chromatographic and spectrophotometric methods for estimation of gliflozin in bulk and in different dosage forms. J Glob Trends Pharm Sci. 2015;6(4).

32.      Harnaskar VR, Datar PA, Shete RV, Gire S. A Review on Analysis of Dapagliflozin. Curr Pharma Res. 2018;8(2):2321-35.

33.      Ziaei E, Emami J, Kazemi M, Rezazadeh M. Simultaneous Determination of Docetaxel and Celecoxib in Porous Microparticles and Rat Plasma by Liquid-Liquid Extraction and HPLC with UV Detection: in vitro and in vivo Validation and Application. J Pharm Pharm Sci. 2020;23:289-303.

34.      Mubeen G, Noor K. Spectrophotometric method for analysis of Metformin. Indian J Pharm Sci. 2009;71(1):100.


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.