A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for determination of Telmisartan in tablet dosage form was developed and validated. Chromatographic separation was achieved on a 250 × 4.6 mm, 5µ, 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 Telmisartan in tablet formulations. The relative standard deviation values for precision was less than 2%, and % recovery was greater than 98% for Telmisartan. The drug undergoes oxidative degradation, thermal degradation and in alkali medium.

A simple, rapid, precise, rapid, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for quantitative analysis of Telmisartan (TELM) in pharmaceutical dosage forms. Chromatographic separation of TELM and its degradation products was achieved on a C 18 , 250 × 4.6 mm, 5µ, Waters symmetry column. The flow rate was 1.0 ml/min, the column temperature 40 0 C, and detection was by absorption at 230 nm using a photodiode array detector. The number of theoretical plates and tailing factor for TELM were 8,721 and 1.018, respectively. TELM was exposed to thermal, photolytic, hydrolytic (acidic and alkali), and oxidative stress, and the stressed samples were analyzed by use of the proposed method. Peak homogeneity data for TELM in the chromatograms from the stressed samples, obtained by use of the photodiode-array detector, demonstrated the specificity of the method for analysis of TELM in the presence of the degradation products. The linearity of the method was excellent over the range 10-50 µg/ml. The correlation coefficient was 0.999. Relative standard deviations of peak areas of all measurements were always less than 2%. The proposed method was found to be suitable and accurate for quantitative analysis of TELM and study of its stability.