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CLINDAMYCIN HYDROCHLORIDE CAPSULES

Category Antibacterial.
          Clindamycin Hydrochloride Capsules contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C18H33ClN2O5S.
Strengths available 75, 150 and 300 mg (base).

Dose Adults: 150 to 450 mg four times a day or up to 1.8 g daily.
          Children: 8 to 20 mg per kg of body weight daily in three or four divided doses.
          In children weighing 10 kg or less, the minimum recommended dose is 37.5 mg every 8 hours.

Contra-indication; Warning; Precaution; Additional information See under Clindamycin Hydrochloride, p. 78.

Packaging and storage Clindamycin Hydrochloride Capsules shall be kept in tightly closed containers, protected from light.

Labelling The label on the container states the quantity equivalent to the amount of clindamycin.

Identification
          A. 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.
          B. Carry out the test as described in the “Thinlayer Chromatography” (Appendix 3.1), using silica gel GF254 as the coating substance and a mixture of 1.5 volumes of strong ammonia solution, 30 volumes of toluene and 70 volumes of methanol as the mobile phase. Apply separately to the plate, 10 μl of each of the following solutions. For solution (A), shake a portion of the capsules contents, equivalent to 50 mg of clindamycin, with 10 ml of methanol and filter. Solution (B) contains 5 mg per ml of Clindamycin Hydrochloride RS in methanol. After removal of the plate, allow it to dry in air and spray with dilute potassium iodobismuthate TS: the principal spot in the chromatogram obtained from solution (A) corresponds to that obtained from solution (B).

Water Not more than 7.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.12).
          Dissolution medium: pH 6.8 phosphate buffer; 900 ml.
          Apparatus 1: 100 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of clindamycin hydrochloride dissolved using the following method.
          Mobile phase Dissolve 16 g of dl-10-camphorsulfonic acid, 8 g of ammonium acetate, and 8 ml of glacial acetic acid in 1600 ml of water, and mix. Add 2400 ml of methanol to this solution, mix and adjust with dilute hydrochloric acid or 5 M sodium hydroxide to a pH of 6.0±0.05.
          Standard solution Prepare a solution of Clindamycin Hydrochloride RS in water having an accurately known concentration similar to that expected in Test solution.
          Test solution Use a filtered portion of the solution under test, diluted with water if necessary.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (30 cm × 4 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (3 μm), (b) Mobile phase at a flow rate of about 2 ml per minute, and (c) a refractive index detector.
          To determine the suitability of the chromatographic system, chromatograph Standard solution, and record the peak responses as directed under Procedure: the symmetry factor for the clindamycin peak is not more than 2.0 and the relative standard deviation for replicate injections is not more than 3.0 per cent
          Procedure Separately inject equal volumes (about 50 μl) of Standard solution and Test solution into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the amount of C18H33ClN2O5S dissolved.
          Tolerances Not less than 80 per cent (Q) of the labelled amount of C18H33ClN2O5S is dissolved in 30 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase Add 2 g of dl-10-camphorsulfonic acid, 1 g of ammonium acetate, and 1 ml of glacial acetic acid to 200 ml of water in a 500-ml volumetric flask, and mix to dissolve. Dilute with methanol to volume, and mix. Adjust, if necessary, with hydrochloric acid or a 50 per cent w/v solution of sodium hydroxide to a pH of 6.0±0.1. Make adjustments, if necessary.
          Internal standard solution Add 0.5 ml of phenylethyl alcohol to a 100-ml volumetric flask, dilute with Mobile phase to volume, and mix.

         Standard preparation Transfer about 90 mg of Clindamycin Hydrochloride RS, accurately weighed, to a suitable container. Add 5.0 ml of Internal standard solution, and swirl to dissolve.
          Assay preparation Remove, as completely as possible, the contents of not less than 20 Clindamycin Hydrochloride Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed portion, equivalent to about 75 mg of clindamycin, to a suitable container. Add 5.0 ml of Internal standard solution, and shake for about 30 minutes. Centrifuge or filter, if necessary, to obtain a clear solution.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (30 cm × 4 mm) packed with 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) a refractive index detector.
          To determine the suitability of the chromatographic system, chromatograph Standard preparation, and record the peak responses as directed under Procedure: the relative retention times are about 1.7 for clindamycin and 1.0 for phenylethyl alcohol, the resolution factor between the clindamycin hydrochloride and the phenylethyl alcohol peaks is not less than 5.0, and the relative standard deviation for replicate injections is not more than 2.0 per cent.
          Procedure Separately inject equal volumes (about 25 μl) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms and measure the responses for the major peaks.
          Calculation Calculate the content of C18H33ClN2O5S in the portion of the Capsules taken, using the declared content of C18H33ClN2O5S in Clindamycin Hydrochloride RS.

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

MONOGRAPHS • CLINDAMYCIN HYDROCHLORIDE CAPSULES
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หมายเหตุ / Note : TP II 2011 PAGE 80 - 81