Development and Validation of a UV-Visible Spectrophotometric Method for Quantitative Estimation of Empagliflozin in Tablet Dosage Forms

Abstract

A simple, rapid, and economical UV-visible spectrophotometric method was developed and validated for the quantitative estimation of empagliflozin in tablet dosage forms. Empagliflozin exhibited maximum absorbance (λmax) at 224 nm in ethanol. The method showed good linearity in the concentration range of 2-12 µg/ml with a correlation coefficient (R2) of 0.999. The proposed method was validated according to the guidelines of the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human use Q2(R1) for linearity, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ). The percentage recovery ranged from 99.90 % to 100.07 %, indicating good accuracy of the method. Precision studies showed %RSD value below 2%, demonstrating acceptable repeatability. The LOD and LOQ were found to be 0.218 µg/ml and 0.661 µg/ml, respectively. The developed method was successfully applied for the assay of empagliflozin in marketed tablet formulation and was found to be suitable for routine quality control analysis due to its simplicit, accuracy and cost-effectiveness.