ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NEW STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN TABLET DOSAGE FORM

  • Geetha Susmita A Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati - 517 502, Chittoor, Andhra Pradesh, India.
  • Rajitha G Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati - 517 502, Chittoor, Andhra Pradesh, India.
  • Ramya Yadav Y Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati - 517 502, Chittoor, Andhra Pradesh, India.
  • Uma P Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati - 517 502, Chittoor, Andhra Pradesh, India.

Abstract

Objective: The objective of this study was to develop and validate a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of the metformin and empagliflozin in tablet dosage forms.

Methods: The chromatographic conditions were optimized and it was run through Std. BDS (250 mm × 4.6 mm, 5 m) column with mobile phase consisting of 0.1% orthophosphoric acid buffer: acetonitrile in the ratio of 50:50. The flow rate was 1 ml/min and optimized wavelength was 210 nm. Temperature was maintained at 30°C.

Results: The retention times of metformin and empagliflozin were found to be 2.588 min and 3.679 min and percentage relative standard deviation (RSD) of the metformin and empagliflozin was found to be 0.59 and 1.2, respectively. Percentage recovery was in the range of 100.01–100.65% for metformin and empagliflozin, respectively.

Conclusion: A sensitive, rapid, and specific method has been developed for the simultaneous estimation of metformin and empagliflozin using RP-HPLC in tablet dosage form.

Keywords: Metformin, Empagliflozin, Reverse-phase high-performance liquid chromatography, Validation, Stability indicating.

Author Biography

Geetha Susmita A, Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati - 517 502, Chittoor, Andhra Pradesh, India.
Department of Pharmaceutical Analysis

References

1. Kar M, Choudhury PK. HPLC method for estimation of metformin hydrochloride in formulated microspheres and tablet dosage form. Indian J Pharm Sci 2009;71:318-20.
2. Shyamala KN, Mounika J, Nandini B. Validated stability-indicating RP-HPLC method for determination of Empagliflozin. Pharm Lett 2016;8:457-64.
3. Venkata SM, Ram BJ, Rajan DS, Adinarayana G, Ramana MK. Development of a validated HPLC method for the estimation of metformin HCl and propranolol HCl. Br J Pharm Res 2014;4:1909-22.
4. Lakshmi KS, Rajesh T, Sharma S. Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms. Int J Pharm Pharm Sci 2009;1:162-6.
5. Pandya RH, Rathod R, Maheswari DG. Bioanalytical method development and validation for simultaneous determination of linagliptin and metformin drugs in human plasma by RP-HPLC method. Pharmacophore 2014;5:202-18.
6. Murthy TG, Geethanjali J. Development of a validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and rosuvastatin calcium in bulk and in-house formulation. J Chromatogr Sep Tech 2014;5:1-7.
7. Kavitha KY, Geetha G, Hariprasad R, Kaviarasu M, Venkatnarayanan R. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of linagliptin and metformin in pure and pharmaceutical dosage form. J Chem Pharm Res 2013;5:230-5.
8. Ramesh J, Kumar NS. Stability indicating RP-HPLC method development and validation for he simultaneous determination of vildagliptin and metformin in pharmaceutical dosage form. Int J Pharm Pharm Sci 2017;9:150-7.
9. Validation of Analytical Procedures. Text and Methodology. Geneva: Q2 (R1); 1996.
10. Validation of Analytical Procedures: Text and Methodology. ICH Q2 (R1) Harmonised Tripartite Guideline; 2006;15-64.
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Susmita A, G., R. G, R. Yadav Y, and U. P. “ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NEW STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN TABLET DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 1, Jan. 2019, pp. 241-4, doi:10.22159/ajpcr.2019.v12i1.26537.
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