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Category Antibacterial; antiprotozoal.

      Oxytetracycline 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 C₂₂H₂₄N₂O₉.

Strength available 250 mg (base).

Dose Adults: 250 to 500 mg every 6 hours.

      Children over 8 years of age: 6.25 to 12.5 mg per kg of body weight every 6 hours.

Contra-indication; Warning; Precaution; Additional information See under Tetracycline Hydrochloride, p. 157.

Packaging and storage Oxytetracycline 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 oxytetracycline.

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. To 0.5 mg of the capsule contents add 2 ml of sulfuric acid: a deep crimson colour is produced. Add 1 ml of water: the colour changes to yellow.

      C. Dissolve 2 mg of the capsule contents in 5 ml of a 1 per cent w/v solution of sodium carbonate and add 2 ml of diazobenzenesulfonic acid TS: a light brown colour is produced.

      D. It yields the reactions characteristic of chlorides (Appendix 5.1).

Loss on drying Not more than 5.0 per cent w/w after drying about 100 mg of the capsule contents in a capillary-stoppered bottle at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: water; 900 ml.

      Apparatus 2: 75 rpm.

      Time: 60 minutes.

Procedure Determine the amount of C₂₂H₂₄N₂O₉ dissolved from absorbances at the maximum at about 273 nm of filtered portions of the test solution, suitably diluted with water, in comparison with a standard solution having a known concentration of Oxytetracycline RS in the same medium, using 5 ml of 0.1 M hydrochloric acid to dissolve the standard (Appendix 2.2).

      Tolerances Not less than 80 per cent (Q) of the labelled amount of C₂₂H₂₄N₂O₉ is dissolved in 60 minutes.

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

      Tetrabutylammonium hydrogensulfate solution, Disodium edetate solution, Phosphate buffer pH 7.5, Mobile phase, Standard preparation, System suitability preparation, Chromatographic system, and Procedure Proceed as directed in the Assay described under Oxytetracycline Hydrochloride, p. 138. 

      Assay preparation Remove, as completely as possible, the contents of not less than 20 Oxytetracycline Hydrochloride Capsules, and weigh accurately. Mix the combined contents, and transfer an accurately weighed portion, containing about 100 mg of oxytetracycline, to a 500 ml-volumetric flask, add 50 ml of 0.01 M hydrochloric acid, and swirl to dissolve. Dilute with 0.01 M Shydrochloric acid to volume, mix and filter.

      Calculation Calculate the content of C₂₂H₂₄N₂O₉ in the portion of the Capsules taken, using the declared content of C₂₂H₂₄N₂O₉ in Oxytetracycline Hydrochloride RS.

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