Novel RP-HPLC Method for the Determination of Paroxetine in Pure Form and in Tablet Formulation

Abstract

Aim: To provide simple, rapid, reproducible reverse phase HPLC method for the estimation of paroxetine in pure form and tablet formulation. Method: The method is optimised using an inertsil column C18 (250x4.6 mm, 5μm) with the mobile phase consists of 10mM ammonium formate and acetonitrile in the ratio of 50:50v/v at an isocratic flow rate of 1ml/min. The detection is carried out at 220nm. Results: The calibration curve is linear in the concentration range of 5-25 μg/ml. The method is statistically validated for its linearity, precision, accuracy, stability and specificity as per ICH Q2R1 guidelines and the method is found to be robust. The LOD and LOQ values were found to be 0.748 and 2.62 μg/ml respectively. Conclusion: Hence the proposed method was found to be precise, accurate, LCMS compatible and can easily adaptable for quality control of paroxetine in dosage forms , biological fluids, dissolution studies.