2996 Mctoclopramide Preparations (Hypersl ODS is suitable), (b) as the mobile phase with a flow rate of 2 ml per minute a mixture of 1 volume of perchloric acd, 45 volumes of methanol and 54 volumes of ‘eater the pH of the mixture being adjusted to 3.0 with 13.501 ammonia and (c) a detection wavelength of 275 nm. For solution (1) allow the chromatography to proceed for at least 3 times the retention time of the principal peak. The test is not valid unless, in the chromatogram obtained with solution (4), the resolution factor between the two principal peaks is at leas 5. In the chromatogram obtained with solution (1) the area of ny peak corresponding to desacetylmetipranolal is not sreater than the area of the principal peak in the chromatogram obtained with solution (3) (2%) and the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained. with solution (2) (0.5%). ASSAY Carry out the method for liguid chromatography, Appendix III, using the follewing solutions. For sotution (1) diture a volume of the eye drops, if necessary, with Sulficient methanol to produce a solution containing 0.10% wiv of Metipranolol. Solution (2) isa 0.10% wiv solution of metipranolol BPCRS in mithanol. Solution (3) contzins 0.02% wiv of matpranolol BPCRS and 0.02% wiv of desacetybneipranolal BPCRS in methanol ‘The chromatographic procedure described under Related substances may be used. The Assay is not valid unles, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at leas 5. Calculate the content of Cj7HayNO, in the eye drops using the declared content of C,;H;NO, in metiranolol BPRS. STORAGE, “Matipranolol Eye Drops should be protected from light The eye drops should not be allowed to freze, IMPURITIES ‘The impurities limited by the requirements of this ‘monograph inelude those listed under Metipranolol Metoclopramide Injection ‘Action and use Dopltnine receptor antagonist; antiemetic. DEFINITION Metoclopramide Injection isa sterile solution of Metoclopramide Hydrochloride in Water for Injections free from dissolved air. ‘The iniection complies with the requirements sated under Parenteral Preparations and wth the follwing requirements. Content of anhydrous metoclopramide hydrochloride, CH, CIN,O;,HCL 90.0 to 110.0% of the stated amount (CHARACTERISTICS A colourless solution, IDENTIFICATION A. In the tes 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. To a volume containing the equivalent of 30: anhydrous metoclopramide hydrochloride add 5 = and 5 ml of a 1% wiv solution of 4-HCI in ide Injection should be protected from light. ING ity of active ingredient is stated in terms of the it amount of anhydrous metoclopramide lorie. oclopramide Oral Solution mand use ne receptor antagonist; antiemetic 10N clopramide Oral Solution isa solution of ide Hydrochloride in suitable favoured oral solution complies with the requirements stated under Liguids and with he follwing requirement nt of anhydrous metoclopramide hydrochloride, light absorption, Appendix IL B, ofthe final solution din the Assay exhibits a maximum at 534 nm, nthe test for Related substances the retention time of the cipal peak inthe chromatogram obtained with solution 4 similar to the retention time of the principal peak in ‘chromatogram obtained with solution (3) ‘substances the Solutions from light, Carry out the method for ‘chromatography, Appendix ID, using the following ‘Mix a quantity ofthe oral solution containing the alent of 10 mg of anhydrous metoclopramide pride with sufficient of the mobile phase to produce sm] and fiter. (Whatman GFIC fier paper i suitable), Dilute 1 volume of solution (1) to 200 volumes with the phase 0.00059 wiv of metoclopramide hydrochloride BPORS in ‘mobile phase SROMATOGRAPHIC CONDITIONS ‘Use a stainless steel column (20 cm x 4.6 mm) packed in octadeci sica gel for chromatography (10 jn) ODS 1 is suitable, Use isocratic elution and the mobile phase described p Use a flow rate of 2 ml per minute, ‘Use an ambient column temperature ‘Use a detection wavelength of 265 nm, Inject 20 ul ofeach solution. Metoclopramide Preparations 2997 MOnILE PHASE 0.016 sodvom hesanesulphonate in a mixture of 40 volumes of ‘water and 60 volumes of acetic, adjusted to pH 4.0 with lacial acztie acid Lnrrs In the chromatogram obtained with solution (1) the area of any secondary peak isnot greater than the area of the principal peak in the chromatogram obtained with solution (2) (05%). Disregard any peaks with a retention time relative to the principal peak of 0.5 or less, ASSAY Protect the solutions from light. Dilute a quantity of the oral solution containing the equivalent of 10 mg of anhydrous ‘metoclopramide hydrochloride to 100 ml with eater, To 5 ml of this solution add 5 ml of 1M Aydhochlnc acid, mixy add 5 ml ofa freshly prepared solution containing 1% wiv of sodivon mate, mix and allow to stand for 10 minutes. Add '5 ml ofa freshly prepared solution containing 5% wiv of ‘ammonium suiphamate, ix and allow to stand for 25 minutes. Add 5 ml of a freshly prepared solution ‘containing 0.5% wiv of N-(I-naphthy!)clslonediamine iydrchloride in Iw hydrochloric acid, mis, add sufficient ‘water to produce 100 mi, mix and allow to stand for 5 minutes. Measure the absorbance of the resulting solution at the maximum at 534 nm, Appendix IB, using rater in the reference cell. Calculate the content of G\Hs.CINO3HCI from the abwrbance obtained by repeating the procedure using 5 ml of a 0.01% wy solution of metoclopramide Jrydrehlorde BPCRS in place of the solution being examined, beginning at the words ‘add 5 mi of Int ydrachloric acid... *, and using the declared content of Cy4Hs,CIN,O3,HCI in ‘maoclopramide hydrochloride BPORS. STORAGE ‘Metoclopramide Oral Solution should be protected from Tight LABELLING The quantity of active ingredient is seated in terms of the equivalent amount of anhydrous metoclopramide hydrochloride. Metoclopramide Tablets Action and use Dopamine receptor antagonist; antiemetic. DEFINITION “Metoclopramide Tablets contain Mewoelopramide Hydrochloride. ‘The tablets comply eth the requirements sated under Tables and wth he fllocing requirement Content of anhydrous metoclopramide hydrochloride, 14Hl,CIN,O;,HCL 90.0 10 110.0% 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), BB. Shake a quantity ofthe powdered tablets containing the equivalent of 50 mg of anhydrous metoclopramide