Volume No. :   6

Issue No. :  4

Year :  2016

ISSN Print :  2231-5667

ISSN Online :  2231-5675


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



Address:   Sushil D. Patil*, Dr. Sunil V. Amurutkar, Dr. C.D. Upasani
Department of Pharmaceutical Chemistry, SNJB’s (Jain Gurukal) Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad-423101
*Corresponding Author
DOI No: 10.5958/2231-5675.2016.00030.2

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.
KEYWORDS:
HPLC, Empagliflozin, Method Development and Validation, ICH Guideline.
Cite:
Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016; 6(4): 201-206.
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