METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF FLUPIRTINE MALEATE AND PARACETAMOL BY RP – HPLC TECHNIQUE

The present study describes a simple, accurate and precise RP-HPLC Technique for the simultaneous determination of Flupirtine maleate and Paracetamol in pharmaceutical dosage form. The method involves an isocratic elution of drug in a stationary phase of Phenomenex, C18 (150mm × 4.6mm, 5µm) column using a mobile phase composition of methanol and 0.1% (v/v) orthophosphoric acid in the composition ratio of 60:40 v/v with a flow rate of 0.8 mL/min at 270 nm of detection. The injection volume is 20 µL. the method has been validated for specificity, linearity, range, precision, accuracy, limit of detection, limit of quantification, ruggedness and robustness. The retention times for Flupirtine maleate and Paracetmol are about 3.07 and 4.63 minutes respectively. Quantitative linearity was observed over the concentration range of 10.08 to 302.51 µg/mL for Flupirtine maleate and 4.99 to 99.80 for Paracetamol respectively. The regression equations of concentration of Flupirtine maleate and Paracetamol are found to be y = 1774x+4755, y = 39182x + 64154 respectively where y is the peak area and x is the concentration of drug (µg/mL). The % recovery of Flupirtine maleate and Paracetamol are found to be in the range of 97% to103 %. All the validation parameters are within the acceptance range