A stability indicating assay method development and validation for the estimation of empagliflozin and metformin hydrochloride

Abstract

The purpose of the investigation was to develop a simple, rapid and accurate RP-HPLC method to determine assayof Metformin Hydrochloride and Empagliflozin in Bulk. The chromatographic separation was performed on Kromosil 250 x 4.6 mm, 5µm. Eluents were monitored on PDA detector at a wavelength of 233 nm using a Buffer: Acetonitrile (45:55v/v). The column temperature was maintained at 30°C. Validation parameters suchas systemsuitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the ICH guidelines. The retention time for Metformin Hydrochloride and Empagliflozin was 2.270 min and 3.413 min respectively. Assay method further evaluated for Metformin Hydrochloride and Empagliflozin analysis at low concentration of analyte and found limit of detection is 0.48 and 0.016 ppm respectively and limit of Quantitation is 1.49 and 0.049 ppm respectively. The percentage recovery of Metformin Hydrochloride and Empagliflozin was 99.64% and 99.47% respectively. The %RSD for Metformin Hydrochloride and Empagliflozin was less than 2. Linearity of Metformin Hydrochloride and Empagliflozin performed from 25% to150% and the R2 is 0.999, intercept and slope found to be y = 26850x + 439840 and y = 47664x + 9394.7 respectively. The method was fast, accurate, preciseand sensitive hence it can be employed for routine quality control of Metformin Hydrochloride and Empagliflozin containing drug in quality control laboratories and pharmaceutical industries.