Abstract

Background: Metoclopramide is a widely prescribed antiemetic drug. Its analysis in pharmaceutical formulations often involves procedures using high amounts of toxic chemicals.

Objective: A method based on micellar liquid chromatography to determine metoclopramide hydrochloride in several oral dosage forms has been developed.

Methods: The drug was resolved from matrix compounds within 6 min using a C18 column with isocratic elution at 1 mL/min utilizing a solution of 0.10 mol/L sodium dodecyl sulfate – 6 % 1- pentanol phosphate buffered at pH 7 as mobile phase, and detection by absorbance at 210 nm. Samples were dissolved or diluted in the mobile phase and directly injected; thus, only one solution had to be prepared for the entire procedure. Besides, it contained mainly harmless chemicals and a minimal amount of organic solvent. Results The procedure was validated by the International Council of Harmonization guidelines and the results were: specificity, calibration range (0.5 – 5.0 mg/L), linearity (r2 > 0.9990), trueness (98.1 – 100.3 %), precision (< 0.7%), robustness, carry-over effect, and system suitability. It was used to analyze commercial samples. Otherwise, it was found the influence of the surfactant on elution strength was nearly three times stronger than that of 1-pentanol.

Conclusion: The procedure was reliable, easy-to-conduct, safe, eco-friendly, short-time, widely available and highly sample-throughput, and then useful for routine analysis of metoclopramidebased dosage forms in pharmaceutical quality control.

Keywords: Absorbance spectroscopy, antiemetic, green, pharmaceutical, retention, validation.