Validation of a Rapid and Sensitive HPLC-UV Method for the Quantification of Eprosartan Mesylate in Bulk Drug, Teventen™ and Ultradeformable Lipid Based Vesicular System

Background: Methods reported so far in literature, considered to be less sensitive, uneconomical and time consuming; overall run time more than 10 minutes. Objective: From economic point of view and for the purpose of routine analysis, it was decided to develop a simple, more sensitive, rapid and economical HPLC method for estimation of EM. Method: A HPLC analytical method has been developed for the quantification of eprosartan in bulk drugs and pharmaceutical formulations at 235 nm using HPLC-UV detector. Chromatographic separation was performed on a Waters (R) C-18 column (mu Bondapak (TM) 5 mu m, 150 mm x 3.9 mm i.d). The acetonitrile and potassium dihydrogen orthophosphate buffer (20mM, pH 3) in ratio of 35%: 65% respectively was used as mobile phase; which pumped at a flow rate of 1.2 ml/min. The developed analytical method was validated following ICH guidelines taking linearity, accuracy, precision, sensitivity, selectivity, robustness and stability of method into consideration. Result: The calibration curves were found linear with regression coefficient (r(2)) of 0.99. The developed method was found to be rapid and sensitive; as the retention time for eprosartan was found to be lesser than 5 min and the LOD and LOQ were found to be 0.014 mu g/ml and 0.042 mu g/ml, respectively. Additionally, the developed method was successfully applied for the estimation of eprosartan in pharmaceutical formulations (bulk drug, tablet and ultradeformable lipid based formulation). Conclusion: The developed method was found simple, rapid, accurate, and reproducible for the determination of eprosartan in bulk, tablet and in lipid based formulation.