Analytical Method Development and Validation for the Simultaneous Estimation of Telmisartan and Hydrochlorothiazide by RP-HPLC Method in Bulk and Tablet Dosage Form

https://doi.org/10.54037/WJPS.2021.91213

Abstract

The chromatographic conditions were successfully developed for the separation of Telmisartan and Hydrochlorothiazide by using C₁₈  Column (150mm x 4.6mm)5µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer P^H 4.5 (70:30 v/v), detection wavelength was 268 nm. The Spectroscopic method was done in solvent using methanol and the instrument lab spectrophotometer UV5 software. The instrument used was WATERS HPLC Auto Sampler, Alliance 2695, photo diode array detector, Empower-software version 2. The retention times were found to be about 2.15 min and 3.0 min. The % purity of Telmisartan and Hydrochlorothiazide was found to be 99.86% and 100.1% respectively. The system suitability parameters for Telmisartan and Hydrochlorothiazide such as theoretical plates and tailing factor were found to be 7752, 1.3 and 6467 and 1.2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Telmisartan and Hydrochlorothiazide was found in concentration range of 2µg-25µg and 5µg-100µg and correlation coefficient (r²) was found to be 0.999 and 0.999 respectively, % recovery was found to be 99.86% and 99.96% respectively. %RSD for repeatability and precision was found to be < 2.LOD values were 0.012 and 0.018 and LOQ value was 0.022 respectively for Telmisartan and Hydrochlorothiazide.