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Asian Journal of Pharmaceutical Analysis
Year : 2017, Volume : 7, Issue : 1
First page : ( 18) Last page : ( 22)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2017.00004.7

Development and Validation of Simple UV-Spectrophotometric Method for the Determination of Empagliflozin

Patil Sushil D.*, Chaure Sayali K., Rahman Maswood Ahmed Hafizur, Varpe Prajkta U., Kshirsagar Sanjay

MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, India

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

Online published on 18 September, 2017.

Abstract

A rapid, specific and economic UV Spectrophotometric method has been developed using a solvent composed of water: methanol (9.0:1.0) to determine the empagliflozin content in bulk. At a pre-determined λmax of 224 nm, it was proved linear in the range of 1.0–3.0 μg/mL, and exhibited good correlation coefficient (R2=0.998) and minimum sum of square error 0.0595, Hence we have selected equation of line of 50–90% (best fit line) linearity throughout experiment. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of empagliflozin in bulks as well as in the commercial formulations.

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Keywords

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

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