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Asian Journal of Pharmacy and Technology
Year : 2019, Volume : 9, Issue : 3
First page : ( 208) Last page : ( 211)
Print ISSN : 2231-5705. Online ISSN : 2231-5713.
Article DOI : 10.5958/2231-5713.2019.00035.7

RP-HPLC Method for Quantification of Empagliflozin in Pharmaceutical Formulation

Siridevi Mounika P, Kumar Hemant T*, Rao Srinivasa Y, Rao Vara Prasad K

Department of Pharmaceutical Analysis and Quality Assurance, Vignan Institute of Pharmaceutical Technology, Beside VSEZ, Duvvada, Visakhapatnam-530049

*Corresponding Author E-mail: hemkar_pharma@yahoo.co.in

Online published on 31 December, 2019.

Abstract

A simple, sensitive and specific RP-HPLC method was developed and validated for determination of Empagliflozin in bulk and tablet dosage form. Chromatography was carried out on a Enable C18G (250 x 4.6 mm i.d., 5μ) column using filtered and degassed mixture of methanol and water in the ratio of 70: 30% v/v as mobile phase at a flow rate of 1 ml/min and effluent was monitored at 233 nm. The method was linear over the concentration range of 10–90 μg/ml with a correlation coefficient of 0.999. The retention time of the drug was 6.2 mins. The proposed method was validated by determining sensitivity, accuracy, precision, robustness studies. The developed method was effectively applied to tablets of empagliflozin and the % recovery of empagliflozin from tablet formulation was found to be 99.65–99.89%. The method is simple, accurate, precise and reproducible and hence can be applied for routine quality control analysis of empagliflozin in pure and tablet dosage form.

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Keywords

Empagliflozin, RP-HPLC, Validation, Tablet dosage form.

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