Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF EMPAGLIFLOZIN

Vashi Dhara and Dr. Suresh Kumar*

Abstract

A simple, Precised, Accurate method was developed for the estimation of Empagliflozin by RP-HPLC technique. Chromatographic conditions used are stationary phase YMC ODS A C-18 (150mm x 4.6mm),Mobile phase Acetonitrile : Water in the ratio of 50:50 % v/v and flow rate was maintained at 0.5 ml/min, detection wave length was 224 nm, column temperature was set to 35ºC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 50 μg/ml to 150 μg/ml, R2 value was found to be as 0.999. Accuracy was carried out on level 50 % to 150% and assay value found in range of 99.55 % to 100.56% .Precision was found to be 0.23 for repeatability, 0.40 to 0.59 for interday precision, 0.19 to 0.26 for intraday precision. LOD and LOQ are 1.24μg/ml and 3.75μg/ml respectively. By using above method assay of marketed formulation was carried out 99.40% was present. Empagliflozin was subject to stress condition including alkaline, acidic, oxidation, thermal degradation and photolysis. Empagliflozin is more sensitive towards acid and Alkali degradation. Also there was no interference of excipients and degradation product at retention time of Empagliflozin, indicating specificity of the method.

Keywords: RP-HPLC, Stress Degradation, Method development, Validation, ICH Guideline.