Monday , 24 June 2024

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

L. Kanaka Lakshmi*, S. Harshini, Dr. Vasudha Bakshi, D. Sireesha, Akiful Haque
Deparment of Pharmaceutical Analysis, School of Pharmacy, Anurag Group of Institutions, Ghatkesar, Ranga Reddy, Telangana-501301, India. 

The chromatographic conditions were successfully developed for the separation of Hydrochlorothiazide and Telmisartan by using Agilent C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: ACN, detection wavelength was 274nm.The Spectroscopic method was done in solvent using methanol and the instrument lab india 3000+ with uv win software. The instrument used for HPLC , WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 1.866 mins and 2.496 mins. The % purity of Hydrochlorothiazide and Telmisartan was found to be 99.87% and 100.27% respectively. The system suitability parameters for Hydrochlorothiazide and Telmisartan such as theoretical plates and tailing factor were found to be 4260, 1.2 and 5085 and 1.2, the resolution was found to be 7.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Hydrochlorothiazide and Telmisartan was found in concentration range of 50µg-250µg and 15µg-55µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 98.56% and 99.96%, %RSD for repeatability was 1.2, % RSD for intermediate precision was 1.9. The precision study was precision, robustness and repeatabilty.LOD value was 3.72 and 0.0242 and LOQ value was 7.40 and 0.0202 respectively.
Keywords: Telmisartan, HPLC, Hydrochlorthiazide

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