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Asian Journal of Pharmaceutical Analysis
Year : 2016, Volume : 6, Issue : 4
First page : ( 201) Last page : ( 206)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2016.00030.2

Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin

Patil Sushil D.*, Dr. Amurutkar Sunil V., Dr. Upasani C.D.

Department of Pharmaceutical Chemistry, SNJB's (Jain Gurukal), Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101

*Corresponding Author E-mail: sushilpharma@rediffmail.com

Online published on 2 February, 2017.

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. 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.

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Keywords

HPLC, Empagliflozin, Method Development and Validation, ICH Guideline.

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