STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF TELMISARTAN IN THE DOSAGE FORM

Abstract

A simple, precise, 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 were achieved on a C ₁₈ , 250 4.6 mm, 5?, Waters symmetry column. The flow rate was 1.0 mL/min, the column Temperature 40 ⁰ C, and detection was by absorption at 230.0 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 homogenecity 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 1050 g/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.