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DOMPERIDONE ORAL SUSPENSION

Category Anti-emetic; dopaminergic blocking agent.

         Domperidone Oral Suspension contains not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C22H24ClN5O2. It may contain one or more suitable buffers, colours, flavours, preservatives and suspending agents.

Strength available 1 mg per ml.

Dose Adults: 10 to 20 mg three times a day, 15 to 30 minutes before meals. If necessary, it may be taken again at bedtime.

        Children: 250 μg per kg of body weight three times a day, 15 to 30 minutes before meals. If necessary, it may be taken again at bedtime.

Contra-indication; Warning; Additional information See under Domperidone, p. 94.

Packaging and storage Domperidone Oral Suspension shall be protected from light.

Identification

A. Complies with the test for Identification B described under Domperidone, p. 94.

B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

pH 5.0 to 7.5 (Appendix 4.11).

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

          pH 3.0 Buffer solution Dissolve 2.72 g of potassium dihydrogenphosphate in 900 ml of water and adjust with phosphoric acid to a pH of 3.0±0.1. Dilute with water to make 1000.0 ml.

Mobile phase Prepare a mixture of 53 volumes of pH 3.0 Buffer solution, 30 volumes of methanol and 17 volumes of acetonitrile. Make adjustments if necessary.

Internal standard solution Transfer 100 mg of propranolol to a 50-ml volumetric flask, dissolve in and dilute with methanol to volume, and mix.

Standard preparation 1 Dissolve about 60 mg of Domperidone RS, accurately weighed, in 1 ml of acetonitrile, dilute with Mobile phase to 25.0 ml and mix. 

Standard preparation 2 Transfer 2.0 ml of Standard preparation 1 to a 50-ml volumetric flask, add 5.0 ml of Internal standard solution, dilute with Mobile phase to volume, and mix.

          Resolution solution Dissolve about 20 mg of Droperidol RS, accurately weighed, in 0.5 ml of acetonitrile, dilute with Mobile phase to 20.0 ml and mix. Transfer 4.0 ml of this solution to a 50-ml volumetric flask, add 2.0 ml of Standard preparation 1, 5.0 ml of Internal standard solution and dilute with Mobile phase to volume.

          Assay preparation Transfer an accurately weighed portion of Domperidone Oral Suspension containing about 5 mg of domperidone, to a 50-ml volumetric flask. Add 0.1 ml of acetonitrile and 5.0 ml of Internal standard solution, dilute with Mobile phase to volume and mix.

          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with base-deactivated octadecylsilane chemically bonded to porous silica or ceramic microparticles (5 μm), (b) Mobile phase at a flow rate of about 1 ml per minute, and (c) an ultraviolet photometer set at 280 nm.

          Equilibrate the column for not less than 3 hours before determining the suitability of the chromatographic system, chromatograph Resolution solution and record the peak responses as directed under Procedure: the resolution factor between domperidone and droperidol peaks is not less than 1.5, and the symmetry factor for the domperidone peak is not more than 2.0. The relative retention times are about 0.69 for domperidone, 0.75 for droperidol and 1.0 for propranolol. Chromatograph Standard preparation 2, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.0 per cent.

         Procedure Separately inject equal volumes (about 10 μl) of Standard preparation 2 and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

         Calculation Calculate the content of C22H24ClN5O2 in the portion of the Oral Suspension taken, using the declared content of C22H24ClN5O2 in Domperidone RS.

         Other requirements Complies with the requirements described under “Oral Liquids” (Appendix 1.16).

MONOGRAPHS • DOMPERIDONE ORAL SUSPENSION
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หมายเหตุ / Note : TP II 2011 PAGE 95-96