RAPID ESTIMATION OF ESCITALOPRAM IMPURITIES IN MULTIPLE BRANDS USING COMPREHENSIVE STABILITY INDICATING RP-HPLC METHOD

This study aimed regarding application of comprehensive stability-indicating analytical method for estimation of Escitalopram impurities in multiple brands of pharmaceutical dosage forms using reverse phase high-performance liquid chromatography. The comprehensive stability-indicating analytical method applied utilized an isocratic mode with a C18 column. The mobile phase comprised a phosphate buffer and acetonitrile (75:25v/v) at a flow rate of 1.2ml/min. A sample injection volume of 5μL was employed, and eluted analytes were monitored at 240nm. The utilized method was validated following ICH guidelines and found to be simple, specific, highly sensitive, precise, robust, and linear for Escitalopram in the range of 0.16 to 2.4μg/ml. Similarly, for Escitalopram impurities A, B, D, H, L & C, the observed linearity range was 0.25 to7.5μg/ml. Accuracy range was confirmed for Escitalopram from 0.16 to 2.3μg/ml, Escitalopram impurities A, B, H from 0.3 to 8μg/ml, and Escitalopram impurities C, D, and L from 0.5 to 8μg/ml. The solution demonstrated stability for up to 48 Hrs. Additionally, the applied method was proven to be stability-indicating by subjecting drug products to various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal degradation, and photolytic degradation. Major degradation was observed in oxidation and base conditions, along with mass balance, substantiating the method’s stability-indicating nature. Furthermore, the method was applied to identify and quantify impurities present in multiple brands of Escitalopram pharmaceutical dosage forms, which includes tablets and solutions, indicating comprehensive application of method to ensure the quality and safety of drug products.