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CLOFAZIMINE CAPSULES

Category Antibacterial (leprostatic).

          Clofazimine Capsules contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C27H22Cl2N4.

Strengths available 50 and 100 mg.

Dose Adults: In combination with one or more other antileprosy agents, 50 to 100 mg a day; with recurring leprotic erythema nodosum, up to 300 mg a day may be required.

Warning; Additional information See under Clofazimine, p 81.

Identification
          A. The principal spot in the chromatogram obtained from the Test preparation is similar in position and size to that in the chromatogram of the Standard preparation A as obtained in the test for Chromatographic purity.
          B. Dissolve a portion of the capsule contents, containing 2 mg of clofazimine, in 3 ml of acetone and add 2 drops of hydrochloric acid: an intense violet colour is produced. Add 0.5 ml of 5 M sodium hydroxide: the colour changes to orange-red.

Disintegration Carry out the test as described in the “Disintegration Test for Tablets and Capsules” (Appen-dix 4.23). Disintegration occurs in not more than 15 minutes with discs, simulated gastric fluid TS being used.

Chromatographic purity Carry out the test as described in the “Thin-layer Chromatography” (Appendix 3.1).
          Ammonia solution, Chromatographic system and Procedure Proceed as directed in the Chromatographic purity under Clofazimine, p. 82.
          Standard solutions Dissolve an accurately weighed quantity of Clofazimine RS in dichloromethane, and mix to obtain the Standard solution A having a known concentration of about 0.5 mg per ml. Dilute portions of the Standard solution A quantitatively with dichloromethane to obtain the Standard solutions B and C having known concentrations of 100 and 40 μg per ml, respectively.
          Test solution To a portion of the capsule content, containing 500 mg of clofazimine, add 25 ml of dichloromethane and 25 ml of 0.1 M sodium hydroxide, and sonicate for 30 minutes. Withdraw the dichloromethane layer, and filter through anhydrous sodium sulfate.

Assay
          0.1 M Methanolic hydrochloric acid Pipette 10 ml of hydrochloric acid into a 1000-ml volumetric flask containing about 500 ml of methanol, mix and dilute with methanol to volume.
          Reference solution Pipette 5 ml of dichloromethane into a 50-ml volumetric flask, dilute with 0.1 M Methanolic hydrochloric acid to volume and mix.
          Standard preparation Dissolve an accurately weighed quantity of Clofazimine RS in dichloromethane and dilute quantitatively and stepwise, if necessary, with dichloromethane to obtain a solution having a known concentration of about 75 μg per ml. Transfer 5.0 ml of this solution to a 50-ml volumetric flask, dilute with 0.1 M Methanolic hydrochloric acid to volume and mix.
          Assay preparation Remove, as completely as possible, the contents of not less than 20 Clofazimine Capsules, and weigh accurately. Mix the combined contents, dissolve an accurately weighed portion of the powder in dichloromethane, filter the solution through a pledget of cotton, and dilute quantitatively and stepwise, if necessary, with dichloromethane to obtain a solution having a concentration of about 75 μg per ml. Transfer 5.0 ml of this solution to a 50-ml volumetric flask, dilute with 0.1 M Methanolic hydrochloric acid to volume and mix.
          Procedure Concomitantly measure the absorbances of Standard preparation and Assay preparation at the maximum at about 491 nm, using Reference solution as
the blank (Appendix 2.2).
          Calculation Calculate the content of C27H22Cl2N4 in the portion of the Capsules taken, using the declared content of C27H22Cl2N4 in Clofazimine RS.

Other requirements Comply with the requirements described under “Capsules” (Appendix 1.16).

MONOGRAPHS • CLOFAZIMINE CAPSULES
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หมายเหตุ / Note : TP II 2011 PAGE 82 - 83