STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINING ASSAY AND IMPURITY PROFILING OF TELMISARTAN AND AMLODIPINE IN PHARMACEUTICAL DOSAGE FORMS

Abstract

This study presents the development and validation of a simple, cost-effective, and time-efficient stability-indicating reverse-phase liquid chromatographic (RP-HPLC) method.  The objective of this method is to simultaneously estimate the assay and impurity profiles of Telmisartan and Amlodipine in diverse pharmaceutical formulations. Chromatographic separation of Amlodipine, Telmisartan, and their associated impurities was achieved using a YMC-Triart C18 column (150×4.6 mm, 5 µm particle size).  The mobile phase system consisted of Mobile Phase A (buffer solution and acetonitrile in an 80:20 ratio) and Mobile Phase B (buffer solution and acetonitrile in a 20:80 ratio).  The flow rate was 1 mL/minute, and the injection volume was 20 µL. The column oven and auto-sampler temperatures were maintained at 25 °C, with detection performed at 257 nm.  The method underwent validation according to International Council on Harmonization (ICH) guidelines, demonstrating linearity and accuracy within acceptable criteria, as evidenced by correlation coefficients and percentage recovery.  The requirements for system suitability were also met. This method was developed to quickly and simultaneously measure Amlodipine, Telmisartan, and their impurities. While the drugs exhibited stability, significant degradation was observed under all stress conditions.  This proposed method is suitable for routine analytical applications in the pharmaceutical sector.