A simple, specific and accurate reversed phase high performance liquid chromatographic method was developed and validated for the determination of Eperisone HCl. The determination was carried out using a Thermo C18 (250 x 4.6 mm) 5 μm column and a mobile phase of methanol and water in the proportion of (45:55) pH adjusted with 0.05% o-phosphoric acid. Validation parameters were evaluated for the method according to the ICH (Q2R1) guidelines. Linearity was established for Eperisone HCl in the range of 10 to 50 µg/ml, respectively. The limit of detection and limit of quantitation for the method were 0.286 μg/ml and 0.868 μg/ml, respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible. The intra- and inter-assay precisions were satisfactory; the values of relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of Eperisone HCl was 98.89% to 100.90%. The chromatographic retention time of proposed method was 7.55 min and the mean assay of content was found to be 99.48±0.59%. The proposed method was successfully applied for the quantitative determination of Eperisone HCl in bulk form and could be used for routine analysis with phenomenal accuracy and precisions. The results were validated as per the ICH guidelines. This method can be successfully employed for the quantitative analysis of Eperisone HCl in pure and formulation.
Loading....