A simple, novel, precise and accurate stability indicating RP-HPLC method was developed and validated for the estimation of Eperisone hydrochloride in bulk drug and pharmaceutical dosage form. A Fortis H2O (150 mm × 4.6 mm I.D., 5 µm particle size) column was used as stationary phase with mobile phase consisting of 10 mM ammonium formate: acetonitrile in the ratio of 65:35 v/v (pH was adjusted to 3.8 with 0.1% formic acid). The flow rate was maintained at 1.0 mL/min and effluents were monitored at 259 nm. The retention time was 8.150 min. The linearity of the method was observed in the concentration range of 1-100 µg/mL with correlation coefficient of 0.999. The method developed was validated for linearity, precision, accuracy, system suitability and forced degradation studies like acidic, alkaline, oxidative and thermal stress conditions were performed as per ICH guidelines. The results obtained in the study were within the acceptable limits and hence this method can be used for the estimation of Eperisone hydrochloride in pharmaceutical dosage form.
Key words: Eperisone; HPLC; Validation; Dosage Form.