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Authors
Affiliations
1 Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 6, No 4 (2016), Pagination: 201-206
Abstract
A Stability Indicating RP HPLC method was develop and validated for the determination of Empagliflozin using Phenomenex C18 column (25 cm×4.6 mm, 5μm) with mobile phase consisting of Methanol: Water (70:30% v/v). The flow rate was kept constant 1.0 mL/min and eluent was detected at 224 nm. In calibration curve experiments, Linearity was found to be in concentration range 2-14 μg/mL (R2=0.999) with regression equation Y = 96888x - 25879. Empagliflozin was subject to stress condition including alkaline, acidic, oxidation, wet heat, thermal degradation and photolysis. Empagliflozin is more sensitive towards acid degradation. Also there was no interference of excipient and degradation product at retention time of Empagliflozin, indicating specificity of the method.
Keywords
HPLC, Empagliflozin, Method Development and Validation, ICH Guideline.
