Author(s): B. Mohan Gandhi1, A. Lakshmana Rao2* and J. Venkateswara Rao3
A stability-indicating RP-HPLC method was developed and validated for the estimation of Flupirtine in pharmaceutical dosage forms. An Inertsil ODS C18 column (150 mm x 4.6 mm), 5 µ particle size was used as stationary phase with mobile phase consisting of 0.01M potassium dihydrogen orthophosphate buffer having pH 3.6 adjusted with orthophosphoric acid and acetonitrile in the ratio of 75:25 V/V. The flow rate was maintained at 1 mL/min and effluents were monitored at 246 nm. The retention time was 4.12 min. The stress studies were performed as per ICH guidelines under acidic, alakiline, neutral, oxidative, UV and thermal conditions. The linearity of the method was observed in the concentration range of 100-600 µg/mL with a correlation coefficient of 0.999. The percentage assay of Flupirtine was found to be 99.84 %. The method was validated for its accuracy, precision and system suitability studies. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the estimation of Flupirtine in pharmaceutical dosage forms.