FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Mobile phase— Dissolve 2.7g of sodium acetate in 600mLof water,add 400mLof acetonitrile,and 4mLof tetramethylammonium hydroxide solution in methanol (25%),and mix.Adjust with glacial acetic acid to a pHof 6.5,filter,and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).

Standard stock solution— Dissolve an accurately weighed quantity of USP Metoclopramide Hydrochloride RSin 0.01Mphosphoric acid to obtain a stock solution having a known concentration of about 9mg of anhydrous metoclopramide hydrochloride per mL.

System suitability solution— Transfer about 125mg of benzenesulfonamide to a 25-mLvolumetric flask,add 15mLof methanol,and shake to dissolve.Dilute with 0.01Mphosphoric acid to volume,and mix.Pipet 15mLof this solution and 5mLof the Standard stock solutioninto a 250-mLvolumetric flask,dilute with 0.01Mphosphoric acid to volume,and mix.

Standard preparation— Transfer 5.0mLof the Standard stock solutionto a 250-mLvolumetric flask,dilute with 0.01Mphosphoric acid to volume,and mix to obtain a solution having a known concentration of about 180µg of USP Metoclopramide Hydrochloride RS,on the anhydrous basis,per mL(equivalent to about 160µg of anhydrous metoclopramide per mL).

Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 4mg of metoclopramide,to a 25-mLvolumetric flask,dilute with 0.01Mphosphoric acid to volume,and mix.

Chromatographic system(see Chromatography á621ñ)— Prepare as directed in the Assayunder Metoclopramide Injection.The relative retention times are about 0.2for benzenesulfonamide and 1.0for metoclopramide.

Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of metoclopramide (C14H22ClN3O2)in each mLof the Oral Solution taken by the formula: in which 299.80and 336.26are the molecular weights of metoclopramide and anhydrous metoclopramide hydrochloride,respectively;Cis the concentration,in mg per mL,of USP Metoclopramide Hydrochloride RS,on the anhydrous basis,in the Standard preparation;Vis the volume,in mL,of Oral Solution taken;and rUand rSare the peak responses of metoclopramide obtained from the Assay preparationand the Standard preparation,respectively.