Abstract

Stability indicating HPLC Method for the Determination of Telmisartan as Bulk Drug and in Pharmaceutical Dosage Form

Author(s): B. Udaykumar Rao, Devanand B. Shinde and Anna Pratima Nikalje

This paper describes the validation of an isocratic HPLC method for the assay of telmisartan as bulk and pharmaceutical dosage forms. The solubility of drug is very poor in all solvents. Diluent has been developed to dissolve the drug substance first. The mixture of methanol and acetonitrile 1.5 : 1 was used as a diluent for dissolving the drug substance. The method employs Phenomenex luna ODS, (25 cm x 4.6 mm OD , 5μ, pore size 100Ao) column with a mobile phase with composition phosphate buffer and acetonitrile. 60 : 40. Quantitations was achieved by UV detection at 230 nm.A linear response (r > 0.999) was observed in the range of 300 –1500 >g mL-1. The method shows good recoveries (Average 98.69%) and the relative standard deviation intra and inter-day were found to be 0.57% and 0.05%. Validation parameters as specificity, and robustness were also determined. The method can be used for quality control assay of telmisartan as bulk and in finished dosage form and for the stability studies as the method separates telmisartan from its degration products and exipients