Validation and application of RP-HPLC method for the quantification of metoclopramide hydrochloride in oral formulations prepared for IVIVC studies

ABSTRACT

The objective of this study is to develop sensitive and cost effective reverse phase high performance liquid chromatographic method for the estimation of Metoclopramide Hydrochloride in oral solid dosage formulations. A reverse chromatographic method was used with the mobile phase of Acetonitrile, 20 m M Potassium dihydrogen phosphate buffer solution [pH 3 adjusted with orthophosphoric acid] in the ratio of 4060. The column used was Waters C18 3.9×300 mm microBondapak [RP]. The flow rate of the mobile phase was 2 ml/minute. The detector was set at the wavelength of 275 nm. This method showed good sensitivity. The linearity was also found to be excellent [gamma[2]=0.997] in the range of 5-75 microg/ml. No interfering peaks were observed at the retention time of Metoclopramide Hydrochloride when both placebo and blank samples were injected [Retention time =1.93 min]. The parameters such as specificity, linearity, range, accuracy, precision, system suitability, solution stability, detection and quantification limits were evaluated to validate this method. This method can effectively be used for quantitative analysis of Metoclopramide Hydrochloride tablet formulations because of its specificity, accuracy and convenience of use