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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK AND IN A SYNTHETIC MIXTURE

C. Rupasi Pratyusha*, M. Bhagavan Raju

The purpose of the investigation was to develop a simple, rapid and accurate RP-HPLC method to determine assay of Metformin Hydrochloride And Empagliflozin in Bulk and synthetic mixture. 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 such as system suitability, 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, precise and sensitive hence it can be employed for routine quality control of Metformin Hydrochloride and Empagliflozin containing drug in quality control laboratories and pharmaceutical industries.


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