Simple and stability indicating RP-HPLC assay method development andvalidation of telmisartan in bulk and dosage form

摘要

A new simple, accurate, precise, sensitive and validated by RP-HPLC method was developed for the estimation of Telmisartan in bulk and pharmaceutical dosage form. The Chromatographic conditions used for the separation was Zorabax SBC18(150x4.6 MM, 5μ) and the mobile phase comprised of Acetonitrile and (0.1ml Phosphoric acid and 0.2ml Try Ethyl Amine in100mlof Triple distilled Milli-Q-water) Buffer (35:65 v/v). The flow rate was 1.2 ml/ 1minute with the detection at 234 nm. The Assay method was validated as per ICH guidelines. The retention time was found to be 5.332 minutes. The linearity was found to be in the range of 0.1 – 0.6 mg/ml (25% to 150%) with correlation coefficient (r) 0.9996. The proposed method is accurate with 99.8576% - 99.988% recovery for Telmisartan and precise. %RSD of repeatability, intraday and inter day variations were 0.2125 - 0.98. The method can be successfully applied to pharmaceutical formulation.