Method Development and Validation of Domperidone Malate in Tablet Dosage Form by Using RP-HPLC Method

Abstract

A simple, precise, dependable, and replicable HPLC technique was developed to analyze Domperidone in solid dosage forms. The method utilized a C18 column with a mobile phase consisting of KH2PO4 Buffer and Methanol in a ratio of 60:40 (v/v), with detection performed at 253 nm. Domperidone exhibited a retention time of 6.7 minutes. Validation of the method was conducted following ICH guidelines, demonstrating satisfactory linearity, accuracy, and precision. The limit of detection and limit of quantification were determined to be 0.36 µg/mL and 1.56 µg/mL, respectively. This method proved suitable for the routine analysis of Domperidone, both individually and in combination with other dosage forms.