Friday , 29 March 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Candesartan cilexitil and Hydrochlorothiazide by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Idavalapati Chandana*, M. Gobinath, V. Haribaskar, Ramesh Dhani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore, Andhra Pradesh, India

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Candesartan cilexitil and Hydrochlorothiazide  by using zodiac sil C18 Column (150mm x 4.6mm)5µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer PH 3 (70:30 v/v), detection wavelength was 240 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, UV detector, Empower-software version 2. The retention times for Candesartan cilexitil and Hydrochlorothiazide were found to be 2.170 min and 7.025 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Candesartan cilexitil and Hydrochlorothiazide was found in the concentration range 16 ppm-80 ppm and 25ppm -125 ppm and correlation coefficient (r2) was found to be 0.999 and 0.999 respectively, % recovery was found to be 101.7% and 102.0% respectively. %RSD for repeatability and precision was found to be <2. LOD values for candesartan cilexitil, Hydrochlorothiazide were found to be 2.17 and 6.60 respectively and LOQ values for candesartan cilexitil, Hydrochlorothiazide were found to be 6.60 and 0.1125 respectively.  
Keywords: Candesartan cilexitil, Hydrochlorothiazide, HPLC

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