Stability Indicating Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage form by using RPHPLC

Authors: Devi NK* and Sarang SD

DOI: 10.23880/oajpr-16000235

Volume 5, Issue 2

Abstract

An easy reverse stage HPLC approach was created for the determination of Empagliflozin existing wholesale as well as pharmaceutical dosage forms. A Kromasil 100-C18 (250 X 4.6 mm, loaded with 5μ) column in an isocratic mode with mobile stage Acetonitrile: Phosphate barrier [Pot.dihydrogen Orthophosphate 2.725 gm + Dipottasium hydrogen orthophosphate 0.525 gm, 50:50% V/V] effluent was monitored at 301nm. The retention times were 3.333 minutes (± 0.5). The flow rate was 1ml min and also injection quantity was 20μl. The run time offered was 10 mins. The recommended technique was likewise verified. Conclusion: The proposed method was straightforward, delicate as well as dependable with excellent precision and accuracy. The recommended approach specifies while estimating the industrial formulations without disturbance of excipients and also other additives. Thus, this method can be used for the regular determination of Empagliflozin in pure examples and pharmaceutical formulas.

Keywords: Empagliflozin; RP-HPLC; Stability studies; Methanol

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