Abstract

STRESS DEGRADATION STUDIES ON CANDESARTAN CILEXETIL BULK DRUG AND DEVELOPMENT OF VALIDATED METHOD BY UV SPECTROPHOTOMETRY IN MARKETED TABLET

Anjan Paudel, Ameeduzzafar, Farhan Jalees Ahmad, Mohd Qumbar, Chetan Dhal,Asgar Ali*

Abstract

A simple, accurate, reproducible and cost effective UV- visible Spectrophotometric method has been developed for the estimation of Candesartan cilexetil (CC). Maximum absorbance of CC was found to be 253nm in methanol and developed method was validated as per ICH guidelines Q2 (R1). Beers law was obeyed in the concentration range of 2-25μg/ml having linear equation y = 0.0344x + 0.0184 with correlation coefficient of 0.9993. The purposed method was accurate with 99.667– 100.125% and precise (% RSD of intra-day, inter-day variations were 0.186- 1.665, 0.186- 1.508). The limit of detection (LOD) and limit of quantification (LOQ) were found to be 18.1μg/ml and 54.90 μg/ml respectively. From the validated method assay of Candesartan Sandoz 8 mg tablets was found to be 99.61±0.59%. Further stability studies of drug was carried under the acidic, alkaline, hydrolytic, thermolytic, photolytic and UV degradation. The effect of humidity on bulk drug was also studied. This validated method is suitable for the pharmaceutical companies for the estimation of CC.

Keywords: Candesartan cilexetil, UV Spectrophotometry, Validation, Stress degradation.