Development and Validation of Stability Indicating RP-HPLC Assay Method of Eperisone HCl In Pure and Pharmaceutical Dosage Form

摘要

ABSTRACT Simple, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed and validated for the determination of Eperisone HCl using a Phenomenex Luna C18 (250 x 4.6 mm)  5μm column and a mobile phase of buffer and methanol in the proportion of (30:70) pH 3.0 adjusted with o-phosphoric acid. The retention time of Eperisone HCl were found to be 9.050min respectively. Linearity was established for Eperisone HCl in the range of 50.25 to 150.75µg/ml, respectively. The percentage recovery of Eperisone HCl was found to be in the range of 98.96-99.68% respectively. The selected drug were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, photolytic and UV degradation and the degradation studies revealed, Eperisone HCl is well resolved from the pure form with significant differences in their retention time values. This method can be successfully employed for the quantitative analysis of Eperisone HCl in pure and formulation. Keywords: Eperisone HCl, stability indicating method, RP-HPLC.