A Comprehensive Stability-Indicating Analytic...

A Comprehensive Stability-Indicating Analytical Method for Escitalopram Impurity Analysis by RP-HPLC; Force Degradation Study

Author Name : Anand Radheshyam Tiwari, Dr. Sushama R. Ambadekar, Vijay A. Bagul

DOI: https://doi.org/10.56025/IJARESM.2023.1201241399

ABSTRACT This study aimed to develop a short, robust, sensitive and reliable reverse phase high-performance liquid chromatographic (RP-HPLC) method for the determination of Escitalopram related substances in pharmaceutical dosage forms. The separation of Escitalopram (EST) and its impurities utilized an isocratic mode using C18 (150 × 4.6 mm, 2.7 μm) column with a mobile phase comprising 0.05M phosphate buffer and acetonitrile (75:25v/v) at flow rate of 1.2ml/min. The sample injection volume 5μL was applied and eluted analytes were monitored at 240nm. The developed method underwent validation as per ICH guidelines, demonstrating sensitivity, specificity, precision, robustness, and linearity for EST in the range of 0.16 to 2.4μg/ml with r2 value 1. Similarly, for EST impurity A, B, D, H, L & C, the linearity range was 0.25 to 7.5μg/ml with r2 value 1. The accuracy was confirmed for EST from 0.16 to 2.3μg/ml and for EST impurity A, B, H 0.3 to 8μg/ml, and EST impurity C, D, L 0.5 to 8μg/ml. The solution stability was verified for up to 48Hrs.The method was applied to drug products under various stress conditions, major degradation observed under oxidation and alkali conditions. The validated method found short, novel, sensitive, and stability-indicating for its intended application.