Combination of

Omeprazole and Domperidone

         Capsules

  Manufacturing Process

Omeprazole and Domperidone Capsules

Omeprazole and Domperidone Capsules contain not less than 90.0 per

cent and not more than 110.0 per cent of the stated amounts of

omeprazole C I7H19N303 S and domperidone C22112 4C N5 02

Usual strength. Domperidone. 10 mg and Omeprazole. 20 mg.

Identification

In the Assay, the principal peaks in the chromatogram obtained with

the test solution correspond to the principal peaks in the

chromatogram obtained with the reference solution.

Tests

Dissolution (2.5.2).

Domperidone

-Apparatus No. 1,

  • Medium. 900 ml of 0.1 M hydrochloric acid

  • Speed and time. 100 rpm and 60 minutes.

  • Withdraw a suitable volume of the medium and filter.

  • Determine by liquid chromatography (2.4.14).

  • Test solution. Dilute the filtrate, if necessary, with the

    dissolution medium.

Reference solution. Weigh 20 mg of domperidone RS, transfer to a

200.0 ml volumetric flask, dissolve and dilute to volume with

methanol. Dilute 2.0 ml of this solution to 20.0 ml with the

dissolution medium.

Use chromatographic system as described under Assay. Inject the

reference solution. The test is not valid unless the relative standard

deviation for replicate injections is not more than 2.0 per cent.

D. Not less than 75 per cent of the stated amount of C22H24C1N502.

Omeprazole –

A. Apparatus No. 1,

   â€¢ Medium. 900 ml of 0.1 Mhydrochloric acid,

   â€¢ Speed and time. 100 rpm and 120 minutes.

Withdraw a suitable volume of the medium and filter. Measure the

absorbance of the filtrate, suitably diluted with the 0. 1 M methanolic

sodium hydroxide, if necessary, at the maximum at about 340 nm.

Calculate the content of C 17H19N303S in the medium from the

absorbance obtained from a solution of known concentration of

omeprazole RS prepared by dissolving in minimum volume of 0.1 M

methanolic sodium hydroxide and then diluting with the same solvent.

Not more than 10 per cent of the stated amount of C I7H 19N303S.

B. Apparatus No. 1,

Medium. 900 ml of phosphate buffer pH 6.8 prepared by dissolving

6.8 g of potassium dihydrogen phosphate in 800 ml of water, adjusted

to pH 6.8 with 0.2 M sodium hydroxide and diluted to 1000 ml with

water,

   â€¢ Speed and time. 100 rpm and 45 minutes.

   â€¢ Withdraw a suitable volume of the medium and filter.

   â€¢ Determine by liquid chromatography (2.4.14) Use the

   â€¢ chromatographic system described under Assay.

   â€¢ Test solution. Dilute the filtrate, if necessary, with the

dissolution medium.

Reference solution. Dissolve 20 mg of omeprazole RS in 20

nril’VOlumetiic flask with 0. 1 M sodium hydroxide, shake vigroit:sly

foi-5.minutes and dilute 1 0 ml of the solution with the mobile

phase to produce 50.0 ml

Calculate the content of C I7H19N303S in the medium. D. Not less

than 70 per cent of the stated amount of CloHi2C1NO2.

Uniformity of content. (For containing 10 mg or less) Complies

with the test stated under capsules.

Determine by liquid chromatography (2.4.14), using the

chromatographic system as described under Assay.

Test solution. Disperse one capsules in 60 ml of solvent mixture,

sonicate for 45 minutes, and dilute to 100.0 ml with the mobile phase.

Reference solution (a). A 0.01 per cent w/v solution domperidone RS

in the mobile phase.

Inject the reference solution and the test solution.

Calculate the content of C 22H24C1N5O2 in the capsule.

Other tests. Comply with the tests stated under Capsules.

Assay. Determine by liquid chromatography Solvent mixture. A

mixture of 20 volumes of water, 40 volumes of methanol and 40

volumes of acetonitrile.

Test solution. Shake a quantity of the mixed contents of 20 capsules

containing 40 mg of Omeprazole in 50 ml of the solvent mixture for

10 minutes and dilute to 100.0 ml with the solvent mixture and filter.

Dilute 5.0 ml of the filtrate to 10.0 ml with the solvent mixture.

Reference solution. Weigh 40 mg of omeprazole RS and 20 mg of

domperidone RS, transfer to a 200.0 ml volumetric flask, dissolve in

the solvent mixture and dilute to volume with the mobile phase.

Chromatographic system

– a stainless steel column 15 cm x 4.6 mm, packed with octylsilane

bonded to porous silica (5 pm),

– mobile phase: a mixture of 65 volumes of a buffer solution

prepared by dissolving 1.4 g of disodium hydrogen phosphate in 1000

ml of water, adjusted to pH 7.5 with orthophosphoric acid and 35

volumes of acetonitrile,

– flow rate: 1 ml per minute, spectrophotometer set at 220 nm,

– injection volume: 20 pl.

Inject the reference solution. The test is not valid unless the tailing

factor is not more than 2.0 and the relative standard deviation for

replicate injections is not more than 2.0 per cent. Inject the reference

solution and the test solution. Calculate the contents of C I7H19N303

S and C,2 1124C1N5Q in the capsules.

Storage. Store protected from light and moisture,