DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) METHOD FOR ASSAY OF PRUCALOPRIDE DRUG SUBSTANCE

Abstract

A reverse phase-high-performance liquid chromatography method can measure tablet Prucalopride content. This procedure is simple, accurate, economical, reliable, and powerful, and it may be repeated. The amount of Prucalopride in a pharmaceutical was previously determined using UV spectroscopy and a few HPLC methods (4.73 minutes’ retention time). New RP-HPLC technique can evaluate bulk and prescription Prucalopride drugs with a shorter retention duration than existing methods. The separation employed RP-HPLC with a mobile phase of 30% Orthophosphoric acid and 70% methanol (v/v). The mobile phase was moved at 1 mL/min, and UV was measured at 225 nm. Prucalopride retained 1.5 minutes under chromatographic conditions. This method was evaluated against ICH standards to assure accuracy, consistency, and reliability. In stress testing, various breakdown products were created. This comprised acid, alkali, boiling water, hydrogen peroxide, dry heat, and UV light. Prucalopride tablets and mass may be evaluated using the specified chemical method.