Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PAROXETIN HYDROCHLORIDE BY UV SPECTROPHOTOMETRY AND RP- HPLC IN ITS PHARMACEUTICAL DOSAGE FORM

Dr. Ramesh Babu Janga* and Suhasini Jala

Abstract

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 EZchrom 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 6.0, acetonitrile in the ratio 60: 40 v/v. An isocratic elution at a flow rate of 1 mL/ min at ambient temperature and using ELICO SL 218 UV-Visible detector to monitor the eluate at 294 nm. The retention time of Paroxetine is found to be 3.20 min and the calibration curve was linear function of drug in the concentration range of 20-100 μg/ mL (r2 = 0.9999). The limit of detection and the limit of quantification was found to be 0.675 μg/mL and 0.795 μg/mL respectively. The recovery (Accuracy) studies were performed and the percentage recovery was found to be 98.60 ± 0.6216%. 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 befeasible for the determination of Paroxetine in bulk and pharmaceutical formulations.

Keywords: RP - HPLC, Paroxetine, Validation, ICH guidelines.