Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NALTREXONE AND BUPROPION HCL IN BULK AND TABLET DOSAGE FORM BY UPL

Hafsa Habeeb* and S. H. Rizwan

ABSTRACT

This research paper has a Simple sensitive, cost effective, precise Ultra Performance liquid chromatography method for The Simultaneous Estimation of Naltrexone and Bupropion HCL in bulk and Tablet Dosage Form was developed and validated in accordance to ICH guidelines. The chromatography was carried out on water x bridge (75*4.6mm & 2.7μm) column using a mixture of ammonium acetate buffer pH 4.0: methanol (65:35) as the mobile phase and it was pumped at a flow rate of 0.6ml/min the detection was carried out at 275 nm the retention time of naltrexone and bupropion was observed at 2.316 min and 3.907 min respectively with good peak shape, resolution (>1.5) and tailing factor (<2). All the method parameters like Linearity, system suitability, Accuracy, Precision, Range, LOD, LOQ, Robustness and Ruggedness shows great results which was validated statistically. This procedure can be successfully applied for simultaneous estimation of Naltrexone and Bupropion HCL combination for routine quality control Analysis

Keywords: Naltrexone, Bupropion, Mobile phase, run time.