Stability-indicating RP-HPLC method for determination of Eprosartan in pure and pharmaceutical formulation

Abstract

A simple, sensitive and specific RP-HPLC method was developed for the determination of Eprosartan in pure and tablet forms. The method showed a linear response for concentrations in the range of 20-120 ?g/mL using Methanol: Acetonitrile: Buffer solution (Dissolve 0.02 M potassium di-hydrogen orthophosphate in water. Adjust pH of solution to 6.85 with orthophosphoric acid) in the ratio (45:35:20) as the mobile phase with detection at 232 nm using photodiode array (PDA) detector and a flow rate of 1 mL/min and retention time 7.1 min. The value of correlation coefficient, slope and intercept were, 0.9998, 1661.8 and 114.82, respectively. The method was validated as per ICH guidelines for precision, recovery, ruggedness and robustness. The specificity of the method was investigated under different stress conditions including acidic, basic, photochemical and thermal as recommended by ICH guidelines. The drug undergoes degradation under acidic, basic, photochemical and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.