DOI: 10.36347/sajp.2022.v11i02.001

Pages: 37-40

The aim of the present study was to develop and validate a HPLC method for assaying candesartan cilexetil (CAND) in powder preparations prepared from Blopress® Tablets 2 mg. A chromatographic system comprising a YMC AM12S05-1506WT column, the mobile phase of CH3CN:H2O:HClO4:NaClO4=700:300:1:5 (V/V/V/W), a flow rate of 1 mL/min, and a UV detector set at 254 nm was used. The retention time of CAND was approximately 8.8 min. A regression analysis revealed that the calibration curve of the method was linear in the range of 0.10 to 80 µg/mL. Intra-day precision and accuracy ranged between 0.1 and 1.6% and between -0.4 and 20.9%. The accuracy value at 0.10 µg/mL was 20.9%. Inter-day precision and accuracy ranged between 0.2 and 3.0% and between -0.3 and 20.6%. The accuracy value at 0.10 µg/mL was 20.6%. In both cases, accuracy values at 0.10 µg/mL were out of the range of -10% to 10%. Therefore, the limit of quantification was established to be 0.10 µg/mL. The content of Blopress® Tablets 2 mg was 99.20 ± 0.81% (mean ± SD, n=3). The ratios of CAND in powder removed from the mortar, remaining on the mortar and pestle surface, and scattered on the paper to total recovery were 85.48 ± 3.50, 14.27 ± 3.53, and 0.30 ± 0.02%, respectively.