ABSTRACT

The objective of present study is to develop a simple, sensitive, rapid and reproducible validated UV method to quantify empagliflozin in rat plasma and applying the developed method for pharmacokinetic studies of empagliflozin. The method was developed to estimate empagliflozin at 223 nm in ethanol and water using UV spectrophotometer by extracting empagliflozin from rat plasma using liquid extraction with dicloromethane. The developed method was validated as per ICH guidelines. The calibration curve of empagliflozin was linear in the range of 1-30 ?g/ml. Coefficient of Variation for intra and inter-day precision was found to be 0.28 and 0.45 respectively. % Recovery for accuracy study of empagliflozin was found to be between 99.46% to 99.78%. Limits of detection and quantification were found to be 0.10 and 0.33 respectively. The coefficient of variation for robustness and ruggedness was found to be 0.26 and 0.39. Recovery studies were found to be consistent and stability studies were also found to be within the limits. The developed UV method was validated and it was rapid, simple, sensitive and cost effective. The proposed method has been successfully adapted for pharmacokinetic studies of empagliflozin in rats after a single oral dose. Keywords: Empagliflozin, Liquid-liquid extraction, Human plasma, UV-method, Validation
Publication date: 01/12/2020

https://ijbpas.com/pdf/2020/December/MS_IJBPAS_2020_5283.pdf

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https://doi.org/10.31032/IJBPAS/2020/9.12.5283