A Validated Thin-Layer Chromatographic Method for Analysis of Bupropion Hydrochloride in a Pharmaceutical Dosage Form

Abstract

A simple and sensitive thin-layer chromatographic method has been established for analysis of bupropion hydrochloride in pharmaceutical tablets. Chromatography on silica gel 60 F-254 plates with 30:10:1 (v/v) ethanol chloroform glacial acetic acid as mobile phase furnished compact spots at R-F 0.56 +/- 0.01. Densitometric analysis was performed at 254 nm. To show the specificity of the method bupropion hydrochloride was subjected to acid and alkaline hydrolysis, oxidation, photodegradation, and dry and wet heat treatment; peaks of degradation products were well resolved from that of the pure drug. Linear regression analysis revealed a good linear relationship between peak area and amount of bupropion hydrochloride in the range 200-1000 ng per band. The limits of detection and quantitation were 11.45 and 34.71 ng per band, respectively. The method was validated, in accordance with ICH guidelines, for precision, accuracy, robustness, and ruggedness. The intra-day and inter-day repeatability of the method, as RSD, was approximately 1-2%, showing method precision was sufficient. Method recovery was between 102.07 and 104.58% and between 97.20 and 102.19% for quality-control standards and for bupropion hydrochloride in a synthetic mixture, respectively. Statistical comparison of results with those obtained from HPLC analysis proved the method is reproducible and enables selective analysis of bupropion hydrochloride in pharmaceuticals. Because the method could effectively separate the drug from its degradation products, it can be regarded as stability indicating.