Analytical method validation of alfuzosin hydrochloride and its organic impurities by using ultra performance liquid chromatography

Abstract

A low cost ultra-high performance reverse phase liquid chromatography (RPUPLC) method has been proven for the investigation of alfuzosin hydrochloride in the existence of organic pollutants and decomposition products due to forced decomposition products. Attempts have been made to develop several methods for separating drugs from organic impurities. In addition, the best chromatographic separation is Waters Acquity HSS T3 C18, 100 mm × 2.1 mm, UV detection at particle size 1.8, 254 nm, and Perchloric acid (pH 3.5 with sodium hydroxide) with a mixture of organic solvents. This method was endorsed for specificity / selectivity, linearity / range, reproducibility, recovery, and reliability. They can be utilized for quality control during manufacturing and for assessing the stability of commercially available alfuzosin hydrochloride samples. With a gradient time of about 6.0 min and an equilibration time of about 2.0 min, it was possible to analyze more than 100 samples per day. In addition, the pH susceptibility analysis methods referred to in the United States Pharmacopeia and the European Pharmacopoeia were discussed. The Method was successfully validated as per ICH Q2R1 guideline.