Development of a Stability-Indicating UPLC Method for the Determination of Metoclopramide Hydrochloride in Tablet Dosage Form

A simple, sensitive, and reproducible ultra-performance liquid chromatography (UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of Metoclopramide hydrochloride (MTH) tablet dosage forms. Chromatographic separation was achieved on Acquity UPLC BEH C18 50 mm, 2.1 mm, and 1.7 mu m column and a mobile phase consists of 0.1% ortho-phosphoric acid: Acetonitrile (86: 14 V/V) within a short run time of 1.2 min.. The flow rate was 0.5 mL/min, temperature of the column was maintained at 27(0)C, injection volume was 0.5 mu L and detection was made at 213 nm. The developed method was linear for Metoclopramide hydrochloride 10% to 150% of the targeted concentration and the linear regression obtained was 0.9999. Precision, evaluated by intra-and inter-day assay had relative standard deviation (R.S.D) values within 1.31 %. The drug was subjected to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic, and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines for specificity, linearity, accuracy, precision and robustness.