Retention Behaviour of Bupropion Hydrochloride in Reversed Phase Ion Pair LC and Validated Analysis of the Drug in Pharmaceuticals

Abstract

The chromatographic behaviour of bupropion hydrochloride, a basic drug of pK (a) 7.9, has been investigated under reversed-phase ion-pairing conditions and the results were used to develop a method for analysis of bupropion hydrochloride in pharmaceuticals. Chromatographic separation of bupropion hydrochloride and carbamazepine (used as internal standard) was performed on a C-8 column (150 mm x 4.6 mm i.d., 3.5-mu m particle), with 40:10:50 (v/v) methanol-acetonitrile-phosphate buffer (20 mm, pH 3.0), containing 10 mm 1-heptane sulfonic acid sodium salt (1-HSA), as optimum mobile phase at a flow rate of 1.0 mL min(-1). UV detection was at 254 nm. The fully validated method enables reproducible and selective analysis of bupropion hydrochloride in pharmaceuticals.