Abstract

DEVELOPMENT OF VALIDATED STABILITY INDICATING RPHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND CANDESARTAN CILEXETIL FROM TABLET

Y. F. Padole, S. K. Rabade, P. S. Jirvankar, M. J. Umekar and R. T. Lohiya*

Abstract

A simple, isocratic, rapid and accurate reversed phase high performance liquid chromatography method was developed for the quantitative determination of Candesartan Cilexetil and Amlodipine Besylate tablets. The chromatographic separation was achieved on Water Xterra R18, 150×4.6 mm, 3.5u (C18) using Mobile Phase A : ACN: Water: OPA (950:50:01) and Mobile Phase B: ACN: Water: OPA (50:950:01), and the λmax of Amlodipine Besylate was detected at 237nm, where Candesartan Cilexetil exhibits sufficient absorbance at 254 nm. The linear range for Candesartan Cilexetil and Amlodipine Besylate were (2.8-42ppm) and (6.4-96) was obtained with correlation coefficients ≥0.999 for each analyte. The retention time were found to be 4.2 and 8.5 min Candesartan Cilexetil and Amlodipine Besylate respectively. Candesartan Cilexetil and Amlodipine Besylate was subjected to stress conditions (hydrolysis (acid, base) oxidation, photolysis, thermal degradation and humidity degradation) and the stressed samples were analyzed by use of the method. The major degradation was observed in base and minor in acid, thermal, oxidation, humidity and photolysis. The forced degradation studies prove the stability indicating power of the method.

Keywords: Amlodipine Besylate (AMLO) and Candesartan Cilexetil (CANDE), Method validation, RP- HPLC, C18, Degradation Studies.