Metoclopramide Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Metoclopramide Tablets contain an amount of metoclopramide hydrochloride (C₁₄H₂₂ClN₃O₂ · HCl · H₂O) equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of metoclopramide (C₁₄H₂₂ClN₃O₂).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

Mobile phase: Dissolve 2.7 g of sodium acetate in 500 mL of water. Add 500 mL of acetonitrile and 2 mL of tetramethylammonium hydroxide

solution in methanol (1 in 5), and mix. Adjust with glacial acetic acid to a pH of 6.5, filter, and degas.

System suitability stock solution: Transfer 12.5 mg of benzenesulfonamide to a 25-mL volumetric flask. Add 15 mL of methanol, and shake

to dissolve. Dilute with 0.01 M phosphoric acid to volume.

Standard stock solution: 0.9 mg/mL of USP Metoclopramide Hydrochloride RS in 0.01 M phosphoric acid

System suitability solution: Transfer 5 mL of System suitability stock solution and 5 mL of Standard stock solution into a 100-mL volumetric

flask, and dilute with 0.01 M phosphoric acid to volume.

Standard solution: 45 µg/mL of USP Metoclopramide Hydrochloride RS (equivalent to 40 µg/mL of metoclopramide) from Standard stock

solution diluted with 0.01 M phosphoric acid

Sample solution: Nominally 40 µg/mL of metoclopramide, prepared as follows. Weigh and finely powder NLT 20 Tablets. Transfer an

accurately weighed portion of the powder, equivalent to about 40 mg of metoclopramide, to a 100-mL volumetric flask, add about 70 mL of

0.01 M phosphoric acid, and sonicate for 5 min. Cool to room temperature, dilute with 0.01 M phosphoric acid to volume, and mix. Pass the

solution through a filter of 0.45-µm pore size, discarding the first portion of the filtrate. Transfer 10.0 mL of this solution to a 100-mL

volumetric flask, and dilute with 0.01 M phosphoric acid to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 215 nm or diode array. [Note—Use the diode array detector to perform Identification test B.]

Column: 4.6-mm × 25-cm; packing L1

Flow rate: 1.5 mL/min

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

[Note—The relative retention times for benzenesulfonamide and metoclopramide are 0.7 and 1.0, respectively.]

Resolution: NLT 1.5 between the benzenesulfonamide and metoclopramide peaks, System suitability solution

Tailing factor: NMT 2.0 for the metoclopramide peak, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of metoclopramide (C₁₄H₂₂ClN₃O₂) in the portion of Tablets taken:

Result = (r₁ / r₂) × (C₁ / C₂) × (M₁ / M₂) × 100

r₁ = peak response from the Sample solution

r₂ = peak response from the Standard solution

C₁ = concentration of USP Metoclopramide Hydrochloride RS in the Standard solution (µg/mL)

C₂ = nominal concentration of metoclopramide in the Sample solution (µg/mL)

M₁ = molecular weight of metoclopramide, 299.80

M₂ = molecular weight of anhydrous metoclopramide hydrochloride, 336.26

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 900 mL

Apparatus 1: 50 rpm

Time: 30 min

Standard solution: USP Metoclopramide Hydrochloride RS at a known concentration in Medium

Sample solution: Filtered portion of the solution under test, suitably diluted with Medium

Instrumental conditions

Mode: UV-Vis

Analytical wavelength: Wavelength of maximum absorbance at about 309 nm

Tolerances: NLT 75% (Q) of the labeled amount of metoclopramide (C₁₄H₂₂ClN₃O₂) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Mobile phase: Prepare a 1.88 g/L solution of sodium 1-hexanesulfonate solution (0.01 M solution) in a mixture of acetonitrile and water

(60:40), and adjust with glacial acetic acid to a pH of 4.0.

Standard solution: 5.5 µg/mL of USP Metoclopramide Hydrochloride RS in Mobile phase

Sample solution: Shake a quantity of the powdered Tablets containing the equivalent of 100 mg of metoclopramide with 20 mL of methanol

for 5 min, and pass through a suitable filter, discarding the first few mL of the filtrate. Dilute a portion of the filtrate with Mobile phase to

obtain a solution containing about 1.0 mg/mL of metoclopramide.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 265 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 2 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.8

Relative standard deviation: NMT 5.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of any individual impurity in the portion of Tablets taken:

Result = (r₁ / r₂) × (C₁ / C₂) × (M₁ / M₂) × 100

r₁ = peak response of each impurity from the Sample solution

r₂ = peak response of metoclopramide from the Standard solution

C₁ = concentration of USP Metoclopramide Hydrochloride RS in the Standard solution (µg/mL)

C₂ = nominal concentration of metoclopramide in the Sample solution (µg/mL)

M₁ = molecular weight of metoclopramide, 299.80

M₂ = molecular weight of anhydrous metoclopramide hydrochloride, 336.26

Acceptance criteria: NMT 0.5% of any individual impurity is found.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature.

USP Reference Standards 〈11〉

USP Metoclopramide Hydrochloride RS