Analytical Method Development and Validation for the analysis of Alfuzosin Hydrochloride and its Related Substances using Ultra Performance Liquid Chromatography

Abstract

A low-cost reverse phase ultra-performance liquid chromatography (RP-UPLC) method for analyzing alfuzosin hydrochloride in the presence of impurities and degradation products from forced decomposition products has been developed. Several method development trials for the separation of drug from impurities were carried out. Furthermore, the best chromatographic separation was attained on a Waters Acquity HSS T3 C18, 100 mm x 2.1 mm, particle size 1.8, UV detection at 254 nm and gradient elution of perchloric acid (pH 3.5 with sodium hydroxide) with a mixture of organic solvents. (acetonitrile, tetrahydrofuan) as mobile phase for drugs. The method has been assessed for specificity/selectivity, linearity/range, repeatability, recovery, and reliability, which can be utilized for quality control during production, as well as to assess the stability of alfuzosin hydrochloride samples. The total elution time was  about6.5 minutes, and the equilibration time was approximately 1.5 minutes, allowing for the analysis of more than 100 samples per day.Besides that, the pH sensitive analytical method addressed in the US Pharmacopoeia and the European Pharmacopoeia was discussed.