ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FLUPIRITINE MALEATE AND PARACETAMOL BY USING RP-HPLC

A new RP-HPLC method for the quantitative determination of Flupiritine Maleate and Paracetamol was developed and validated as per ICH guidelines. The drugs were injected into Azilent HPLC system with SPD-20A Detector and C18 column (250×4.6, 5 µm) maintained at ambient temperature and effluent monitored at 240 nm. The mobile phase consisted of 0.1% Orthophosphoric acid: Methanol (50:50 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for flupiritine maleate and paracetamol was linear from 6-300.03µg/ml and 1.25 - 60.08µg/ml (r 2 for Flupiritine Maleate =1.0 and r 2 for Paracetamol = 0.99). The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Flupiritine Maleate and Paracetamol in bulk and pharmaceutical dosage form. Keywords: Flupiritine Maleate and Paracetamol, Linearity, Validation.