Development and validation of rapid RP- HPLC method for thedetermination of Paroxetine in bulk and pharmaceutical dosage form

摘要

A simple, reliable, sensitive, precise, rapid, and reproducible RP -HPLC method was developed and validated for the determination of Paroxetine in pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a Welchrom C18 isocratic column, (250 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature).The mobile phase consisted of phosphate buffer at pH 6.8, acetonitrile in the ratio 50: 50 v/v. An isocratic elution at a flow rate of 1 mL/ min at ambient temperature and using ELICO SL 2203 UV-Visible detector to monitor the eluate at 260 nm. The retention time of Paroxetine is found to be 3.71 min and the calibration curve was linear function of drug in the concentration range of 2-10 μg/ mL (r2 = 0.9999). The limit of detection and the limit of quantification was found to be 0.059 μg/mL and 0.181 μg/mL respectively. The recovery (Accuracy) studies were performed and the percentage recovery was found to be 99.53 ± 0.6327 %. Analytical validation parameters such as selectivity, specificity, linearity, precision and accuracy were studied and % RSD value for all key parameters was less than 2 %. Thus the developed reversed phase HPLC method was found to be feasible for the determination of Paroxetine in bulk and pharmaceutical formulations.