Development of Ultra performance Liquid Chromatography (UPLC) method for the Separation of Alfuzosin Hydrochloride and its organic impurities

Abstract

For assessing alfuzosin hydrochloride in the presence of organic contaminants and degradants by forced breakdown products, a novel, quick, precise, sensitive, specific, and stability-indicating reverse-phase (RP-UPLC) approach was established. Acquity BEH C18 (50 × 2.1 mm,1.7), BEH C8 (50 × 2.1 mm,1.7), Acquity CSH C18 (50 × 2.1 mm,1.8), and Acquity BEH C18 (100 × 2.1 mm,1.7) are among the rapid liquid chromatography columns that have been investigated. Low and neutral pH buffers were also used. Furthermore, the best chromatographic separation was achieved with a Waters Acquity HSS T3 C18, 100 mm × 2.1 mm, particle size 1.8, UV detection at As a mobile phase carrier, (acetonitrile, tetrahydrofuran) is used. The final technique conditions enable excellent impurity separation, which can be used to analyse the stability of alfuzosin hydrochloride commercial samples as well as for quality control throughout production. The gradient time was about 6.5 min, and the re-equilibration time was roughly 1.5 min, allowing for more than 100 samples each day to be analysed. Aside from that, the pH sensitive analytical approach addressed in both the US and European Pharmacopoeias was explored.