Method development and validation for assay of candesartancilexetil and hydrochlorothiazide in tablet dosage form by RP-HPLC

Abstract

A new analytical RP-HPLC chromatographic method was developed and validated for simultaneous estimation of Candesartan cilexetil (CANC) and Hydrochlorothiazide (HCT) in bulk and pharmaceutical dosage form. The method was validated as per ICH guidelines. The separation was carried out by using a mobile phase consisting of methanol:acetonitrile:phosphate buffer pH 3.5 in the ratio of 50:20:30. The column used was X-Terra C8 column with (150mm length and 4.6mm internal diameter with 3.5µm particle size) with flow rate of 1.0ml /min using PDA detector at wavelength of 225 nm and temperature was maintained at 25^oC. The retention times of Candesartan cilexetil and hydrochlorothiazide were 6 min and 2 min respectively. The linearity for Candesartan cilexetil and Hydrochlorothiazide were in the range of 12.8 to 64 mcg/ml and 10-50 mcg/ml respectively with value of LOD found to be 0.03mg/ml and 0.06mg/ml and LOQ were found to be 0.1mg/ml and 0.02mg/ml respectively, which were linear enough showing correlation coefficient of 0.999 in both cases. The present method was specific, sensitive, reproducible, precise, rapid and simple.