Development And Validation Of HPLC-UV Method For Prucalopride Succinate Quantification In Biological Samples

Abstract

Prucalopride succinate is a pharmacologically active compound used in the treatment of gastrointestinal disorders. Accurate and reliable quantification of Prucalopride succinate in biological samples is crucial for pharmacokinetic studies, therapeutic monitoring, and drug development. In this study, we developed and rigorously validated a high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method for the quantification of Prucalopride succinate in human plasma. The method was carried out with an Agilent HPLC with a UV detector. BDS Hypersil C8 Column (250 × 4.6 mm, 5 µ) was used at a flow rate of 1.0 mL/min. Detection was carried out at 276 nm. The mobile phase consisting of a mixture of Methanol: 0.1 % Formic Acid (80:20 v/v) respectively. The method involved sample preparation, chromatographic separation, and UV detection. Developed method demonstrated excellent linearity over a wide concentration range (0.05- 0.5μg/ml) and exhibited precision and accuracy within acceptable limits. The lower limit of quantification (0.05μg/ml) was, indicating the method's sensitivity. These bioanalytical validations play a significant role in the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies of Prucalopride succinate.