High Performance Liquid Chromatography for the Determination of Metoclopramide in Pharmaceutical Preparations Using Pre-column Derivatization with Fluorescamine

Abstract

A simple, rapid and sensitive high performance liquid chromatography (HPLC) method was developed for the determination of metoclopramide in pharmaceutical preparation. The method is based on the derivatization of metoclopramide with fluorescamine. The separation was achieved on a C18 column using methanol-water (70:30, V/V) mobile phase. Fluorescence detector was used at the excitation and emission of 403 and 485 nm, respectively. The method was validated for linearity, limit of detection, limit of quantification, precision, accuracy, recovery, robustness and system suitability. The assay was linear over the concentration range of 1002000 ng/mL. The mean recovery was 100.37%. The proposed method was successfully applied to the assay of metoclopramide in tablet preparation. The preparation was also analyzed with an official method and statistical comparison by t- and F-tests revealed that there was no significant difference between the results of the two methods with respect to mean values and standard deviations at the 95% confidence level.