Experimental design approach by using rapid high performance liquid chromatographic method for the determination of telmisartan Assay in immediate release telmisartan tablets 80mg

A rapid high performance liquid dosage form. A Genesis ODS MG, 50 X 4.6mm, 5 mm or equivalent in isocratic mode, with mobile phase containing a mixture of 0.01 M potassium dihydrogen phosphate buffer (adjusted to pH 2.4 using orthophosphoric acid): methanol: Acetonitrile in the ration of 60:40 v/v) and 0.01 triethylamine : methanol (80:20%v/V) was used. The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 298 nm. The selected chromatographic conditions were found to effectively separate telmisartan (Rt: 4.98 min) having a resolution of 5.67. The method was validated in terms of linearity, accuracy, precision, specificity, limit of detection and limit of quantitation. Linearity for telmisartan were found okay respectively. The percentage recoveries for telmisartan ranged from 99.45-100.99%, respectively. The limit of detection and the limit of quantitation for telmisartan was found to be 1.5 μg/ml and 3.0 μg/ml, respectively. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations. The method gives resolution with a short analysis time (< 10 min). The method parameter was validated and establishes to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the planned method can be used for routine analysis of telmisartan in medical dosage form.