SIMULTANEOUS DETERMINATION OF METOCLOPRAMIDE HYDROCHLORIDE AND PYRIDOXINE HYDROCHLORIDE IN SYRUP USING HPLC METHOD WITH FLUORESCENCE DETECTION: APPLICATION TO HUMAN PLASMA

Abstract

A simple, sensitive, and rapid HPLC method was developed and validated for the simultaneous determination of metoclopramide hydrochloride (MCA) and pyridoxine hydrochloride (PDX). The analysis was carried out on CLC Shim-pack C₈ column (250 × 4.6 mm, 5 µm particle size) using a mobile phase consisting of methanol:0.02 M phosphate buffer mixture (45:55, v/v) of pH 3.0. The mobile phase was pumped at a flow rate of 1 mL/min with fluorescence detection at 308/374 nm. The method showed good linearity over the concentration ranges of 0.004–0.20 and 0.05–1.0 µg/mL for MCA and PDX, respectively, with limits of detection of 0.9 and 11.2 ng/mL. The proposed method was applied for the simultaneous determination of the two studied drugs in their combined syrup with average % recoveries of 100.31 ± 1.19 and 99.63 ± 1.27 for MCA and PDX, respectively. By virtue of its high sensitivity, the developed method was further applied to the determination of MCA in human plasma with mean % recovery of 101.00 ± 7.00.

Keywords:

• fluorescence detection
• HPLC
• human plasma
• metoclopramide hydrochloride
• pyridoxine hydrochloride
• syrup

Notes

*A: methanol; B: 0.02 M phosphate buffer.

*Figures between parenthesis are the tabulated t and F values, respectively at p = 0.05.²³

^a Each result is the average of three separate determinations.

*Figures between parenthesis are the tabulated t and F values, respectively at p = 0.05.²³