Abstract

In this study, a validated method was used to analyze two Metoclopramide products available on the market: premosan and primperan. The chromatographic separation involves a mobile phase with a 50:50 mixture of acetonitrile and buffer 4.6 (v/v). A C18 rapid resolution column (4.6×100 mm, 3.5 µm, Agilent high performance liquid chromatography column) was used for the separation. The λ max of metoclopramide was found to be 248 nm. The analysis was performed with a 20 μl injection volume and a 3.0 min run time. The method showed linearity for metoclopramide within the concentration range of 2-10 μg/ml. Method validation followed International Council for Harmonisation guidelines, assessing specificity, selectivity, linearity, accuracy, precision, and the lower limits of quantification and lower limits of detection. The lower limits of quantification and lower limits of detection for metoclopramide were determined to be 0.80 μg/ml and 0.26 μg/ml, respectively. These methods were found to be effective for the precise quantitative analysis of metoclopramide in pharmaceutical formulations.