A VALIDATED STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HCL AND DAPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM

Authors

  • Mohammad Yunoos BAPATLA COLLEGE OF PHARMACY
  • GOWRI SANKAR D

Abstract

 

Objective: A simple and precise stability indicating reversed-phase high-performance liquid chromatography method was developed and validated
for the simultaneous determination of metformin (MET) hydrochloride and dapagliflozin (DAP) in bulk and pharmaceutical dosage form.
Methods: Chromatography was carried out on hypersil BDS C18 (250 mm × 4.6 mm, 5 μ particle size) column containing mobile phase of buffer (0.1%
orthophosphoric acid) adjusted to pH 6.8 with triethylamine:acetonitrile in the ratio of 50:50%/v/v at a flow rate of 1 ml/minutes. The analyte was
monitored using photodiode array detector at 240 nm.
Results: The retention time was found to be 2.791 minutes and 3.789 minutes for MET hydrochloride and DAP respectively. The proposed method was
found to be having linearity in the concentration range of 85-510 μg/ml for MET (r2=0.99995) and 0.5-3.0 μg/ml for DAP (r2=0.99978), respectively.
The mean % recoveries obtained were found to be 99.66-100.23% for MET and 99.61-100.38% for DAP respectively. Stress testing which covered
acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was
achieved. The developed method has been statistically validated according to ICH guidelines.
Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET
hydrochlorideand DAP in bulk and combined tablet dosage form and in the routine quality control analysis.

Keywords: Dapagliflozin, Metformin hydrochloride, Reversed-phase high-performance liquid chromatography, Forced degradation, Method
validation.

Author Biography

Mohammad Yunoos, BAPATLA COLLEGE OF PHARMACY

ASSOCIATE PROFESSOR

DEPARTMENT OF PHARMACEUTICAL ANALYSIS

References

Tatarkiewicz K, Polizzi C, Villescaz C, D’Souza LJ, Wang Y, Janssen S, et al. Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice. Diabetes Obes Metab 2014;16(4):376-80.

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 Obes Metab 2013;15(9):853-62.

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.

Sanagapati M, Lakshmi DK, Reddy NG, Sreenivasa S. Development and validation of stability - Indicating RP-HPLC method for determination of dapagliflozin. J Adv Pharm Edu Res 2014;4(3):350-3.

Madhukar A, Prince A, Vijay Kumar R, Sanjeeva Y, Jagadeeshwar K, Raghupratap D. A simple and sensitive analytical method development and validation of metformin hydrochloride by RP-HPLC. Int J Pharm Pharm Sci 2011;3(3):117-20.

Rajesh T, Lakshmi KS, Sharma S. Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms. Int J Pharm Pharm Sci 2009;1(2):162-6.

Akula A, Prajwala N, Sandhya M. Development and validation of RP-HPLC method for simultaneous estimation of metformin hydrochloride and Gliclazide in bulk and combined dosage form. Int J Pharm Pharm Sci 2013;5(4):511-7.

Bhoomaiah B, Shree JA. 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.

Prathap GM, Muthukumaran M, Krishnamoorthy B. Development and validation of simultaneously estimation of vildagliptin and metformin hydrochloride by RP-HPLC in bulk and oral dosage form. Int J Adv Pharm Gen Res 2014;2(1):24-33.

Manasa S, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. Int J Pharm Sci Drug Res 2014;6(3):250-2.

Published

2015-05-01

How to Cite

Mohammad Yunoos, and GOWRI SANKAR D. “A VALIDATED STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HCL AND DAPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 8, no. 3, May 2015, pp. 320-6, https://innovareacademics.in/journals/index.php/ajpcr/article/view/5787.

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