Action and use
Dopamine receptor antagonist; antiemetic.
Definition
Metoclopramide Tablets contain Metoclopramide Hydrochloride.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of anhydrous metoclopramide hydrochloride, C14H22ClN3O2,HCl
90.0 to 110.0% of the stated amount.
Identification
A. In the test for Related substances the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (3).
B. Shake a quantity of the powdered tablets containing the equivalent of 50 mg of anhydrous metoclopramide hydrochloride with 5 mL of
water, filter and add to the filtrate 5 mL of a 1% w/v solution of
4-dimethylaminobenzaldehyde in 1
m hydrochloric acid. A yellowish-orange colour is produced.
Related substances
Protect the solutions from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Shake a quantity of the powdered tablets containing the equivalent of 0.1 g of anhydrous metoclopramide hydrochloride with 20 mL of
methanol for 5 minutes, filter (Whatman GF/C filter paper is suitable) and add sufficient of the mobile phase to produce 100 mL.
(2) Dilute 1 volume of solution (1) to 200 volumes with the mobile phase.
(3) 0.0005% w/v of metoclopramide hydrochloride BPCRS in the mobile phase.
chromatographic conditions
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 265 nm.
(f) Inject 20 µL of each solution.
mobile phase
0.01m sodium hexanesulfonate in a mixture of 40 volumes of water and 60 volumes of acetonitrile, adjusted to pH 4.0 with glacial acetic acid.
limits
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Shake a quantity of the powdered tablets containing the equivalent of 20 mg of anhydrous metoclopramide hydrochloride with 80 mL of
water with the aid of ultrasound for 10 minutes and then continue shaking mechanically for 20 minutes. Add sufficient
water to produce 200 mL, filter and use the filtrate.
(2) 0.01% w/v of
metoclopramide hydrochloride BPCRS in
water.
chromatographic conditions
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 305 nm.
(f) Inject 20 µL of each solution.
mobile phase
20 volumes of a solution prepared by dissolving 2.25 g of sodium octanesulfonate and 0.3 g of sodium acetate in sufficient water to produce 1000 mL and adjusting the pH, if necessary, to 3.8 with glacial acetic acid and 80 volumes of methanol.
determination of content
Calculate the content of C14H22ClN3O2,HCl in the tablets using the declared content of C14H22ClN3O2,HCl in metoclopramide hydrochloride BPCRS.
Storage
Metoclopramide Tablets should be protected from light.
Labelling
The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous metoclopramide hydrochloride.