DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF BUPROPION AND NALTREXONE IN PURE FORM AND ITS PHARMACEUTICAL DOSAGE FORM

Abstract:

A Rapid and Precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Bupropion and Naltrexone, in its pure form as well as in tablet dosage form. Chromatography was carried out on X-Terra C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: TEA Buffer pH 4.5: Acetonitrile (65:15:20) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 212 nm. The retention time of the Bupropion and Naltrexone was 2.090, 5.289 ±0.02min respectively. The method produce linear responses in the concentration range of 5-25mg/ml of Bupropion and 45-225mg/ml of Naltrexone. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Bupropion, Naltrexone, RP-HPLC, validation.