Abstract
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® C18 column (µBondapakTM5 µm, 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 (r2) 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 µg/ml and 0.042 µg/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.
Keywords: Eprosartan mesylate, HPLC-UV, teventen, ultradeformable lipid based formulation.
Graphical Abstract
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