Open Access: View PDF

DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.8222.1

Abstract

A simple, accurate, precise RP-HPLC method was developed for the simultaneous estimation of the Metformin and Empagliflozin in the tablet dosage form. Materials and Methods: Chromatogram was run through Std Agilent 18 (150 x 4.6mm, 5μm). Mobile phase taken as 0.1% OPA Buffer: Acetonitrile in 60:40% v/v ratio, and pumped through the column at a flow rate of 1mL/min. The buffer used in this method was 0.1% OPA buffer. The temperature was maintained at 25°C. Results and Discussion: Optimized wave length selected was 245 nm. The retention times of Metformin and Empagliflozin were found to be 2.193 min and 2.668 min respectively. %RSD of the Metformin and Empagliflozin was found to be 1.4 and 0.8 respectively. % Recovery was obtained as 99.66% and 100.24% for Metformin and Empagliflozin respectively. LOD, LOQ values obtained from regression equations of Metformin and Empagliflozin were 0.02, 1.48, and 0.05, 4.93 respectively. Regression equation of Metformin is y = 20952x + 9914.5 and y = 41842x + 571.79 of Empagliflozin. Retention times were decreased and that run time was decreased, The Reverse Phase HPLC isocratic method for Metformin and Empagliflozin is developed and validated as per ICH guidelines. Conclusion: The test method is found to be sensitive, accurate, precise, linear, convenient, and economical that can be adopted in regular quality control tests in Industries..

Keywords : Metformin; Empagliflozin; RP-HPLC; Validation.

Corresponding Author : A Sai Datri, Assistant Professor, Department of Pharmaceutical Analysis, V. V. Institute of Pharmaceutical Sciences, Gudlavalleru, Andhra Pradesh 521356, India.ajay.pharma3006@gmail.com.