Abstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan (TELM) in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 4.6 mm, 5?, Waters symmetry column in gradient mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.5 0.01): acetonitrile (64:40) was used. The quantitation performed at flow rate of 1.0 mL/min at 230 nm and run time was 12 min. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness and stability and method can be extended to the analysis of TELM in tablet formulations. The relative standard deviation values for precision was less than 2%, and % recovery was greater than 98% for TELM. The drug undergoes oxidative degradation, thermal degradation and in alkali medium.
Highlights
Telmisartan (TELM) chemically described as4[(1,4‐dimethyl‐ 2‐ propyl (2,6‐bi ‐1H‐benzimidazol]‐1‐yl) methyl][1,1‐biphenyl]‐2‐carboxylic acid is a potent, long‐lasting, nonpeptide antagonist of the angiotensin II (AT1) receptor that is indicated for the treatment of essential hypertension
The chromatographic conditions were optimized for better resolution by using different buffers like phosphate, acetate and citrate for mobile phase preparation
The mean percentage recoveries obtained for Telmisartan were 100.196
Summary
Telmisartan (TELM) chemically described as4[(1,4‐dimethyl‐ 2‐ propyl (2,6‐bi ‐1H‐benzimidazol]‐1‐yl) methyl][1,1‐biphenyl]‐2‐carboxylic acid is a potent, long‐lasting, nonpeptide antagonist of the angiotensin II (AT1) receptor that is indicated for the treatment of essential hypertension. None of these analytical procedures has been described as a stability-indicating method for analysis of TELM in the presence of its degradation products. The aim of present work is to develop a simple, specific, sensitive, accurate and stability indicating HPLC analytical procedure for the analysis of Telmisartan in tablet dosage form in the presence of its degradation products and related impurities as per ICH guideline [15].
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