Analytical Method Development and Validation for the Simultaneous Estimation of Candesartan and Hydrochlorothaizide by RP-HPLC Method Pharmaceutical Dosage Form

Devanapelly Shashikantha Rao*
Lecturer, Department of Chemistry, C.K.M. Arts and Science College, Warangal- 506006

Abstract
A new method was established for simultaneous estimation of Candesartan cilexitil and Hydrochlorothiazide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Candesartan cilexitil and Hydrochlorothaizide by using Zodiac sil C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer(KH₂PO₄and K₂HPO₄) phosphate pH 3 ( pH was adjusted with orthophosphoricacid), detection wavelength was 240nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.170 mins and 7.025 mins. The % purity of Candesartan cilexitil and Hydrochlorothaizide was found to be 99.1% and 98.2% respectively. The system suitability parameters for Candesartan cilexitil and Hydrochlorothaizide such as theoretical plates and tailing factor were found to be 12294, 1.27 and 10491 and 1.03, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Candesartan cilexitil and Hydrochlorothaizide was found in concentration range of 16µg-80µg and 25µg-125µg and correlation coefficient (r²) was found to be 0.999 and 0.998, % recovery was found to be 101.7% and 102.0%, %RSD for repeatability was 0.8and 0.5, % RSD for intermediate precision was 1.99 and 1.82 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.
Key words: Candesartan Cilexitil, Hydrochlorothiazide, HPLC