Development and validation of RP-HPLC method for simultaneous estimation of Paracetamol and Flupirtine Maleate

Abstract

A simple, validated RP-HPLC method for the simultaneous estimation of Paracetamol and Flupirtine maleate in pharmaceutical dosage form was developed and validated. This method was developed by selecting Inertsil, C18, (250 x 4.6mm, 5μ) column as stationary phase and Methanol: O-Phosporic acid (85: 15 v/v) as mobile phase. Flow rate of mobile phase was maintained at 1 ml/min at ambient temperature throughout the experiment. Quantification was achieved with ultraviolet (DAD) detection at 239 nm. The retention times of Paracetamol and Flupirtine maleate were found as 2.78 min and 3.47 min respectively. The detector response was linear in the concentration range of 65–190 μg/ml and 20–60 μg/ml for Paracetamol and Flupirtine maleate respectively, and the regression coefficients found as 0.998 and 0.999 for Paracetamol and Flupirtine maleate respectively. From recovery studies we concluded that the recovery of Paracetamol and Flupirtine maleate has no interference with any excepients in the formulation. This method has been validated according to ICH guidelines and shown to be Specific, Sensitive, Precise, Accurate, Rugged and Robust. Hence, this method can be applied for routine quality control of Paracetamol and Flupirtine maleate in dosage forms as well as in bulk drug.