สารบัญ

Category Antibacterial (ophthalmic).

          Chloramphenicol Eye Ointment is a sterile preparation containing Chloramphenicol in a suitable base. It contains not less than 90.0 per cent and not more than 130.0 per cent of the labelled amount of C₁₁H₁₂Cl₂N₂O₅.

Strength available 1 per cent w/w.

Dose Topical, to the conjunctiva, a thin strip (approximately 1 cm) of ointment every 3 hours or more frequently.

Contra-indication; Precaution; Additional information See under Chloramphenicol Eye Drops, p. 66.

Packaging and storage Chloramphenicol Eye Ointment shall be stored at a temperature not exceeding 30º.

Identification
          A. Mix a portion of the eye ointment containing 50 mg of chloramphenicol with 10 ml of petroleum ether (boiling range, 40^º to 60^º), centrifuge and discard the supernatant liquid. Repeat this procedure using three 10-ml portions of the same solvent. The dried residue complies with the test for Identification A described under Chloramphenicol Capsules, p. 64.
          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.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase; Chromatographic system and Procedure Proceed as directed in the Assay under Chloramphenicol, p. 63.
          Standard preparation Transfer about 25 mg of Chloramphenicol RS, accurately weighed, to a 100-ml volumetric flask, dissolve in methanol, dilute with methanol to volume, and mix. Transfer 10.0 ml of the resulting solution to a 25-ml volumetric flask, dilute with Mobile phase to volume, and mix.
          Assay preparation Transfer an accurately weighed quantity of Chloramphenicol Eye Ointment, containing about 25 mg of chloramphenicol, to a suitable conical flask, add 20 ml of cyclohexane, mix and sonicate for about 2 minutes. Add 60 ml of methanol, and mix. Filter this mixture, collecting the filtrate in a 100-ml volumetric flask. Wash the filter with methanol, collecting the washings in the volumetric flask. Dilute with methanol to volume, and mix. Transfer 50.0 ml of the resulting solution to a suitable round-bottomed flask, and evaporate to dryness by rotating the flask under vacuum in a water-bath at 35º. Dissolve the residue in 50.0 ml of methanol. Transfer 10.0 ml of the resulting solution to a 25-ml volumetric flask, dilute with Mobile phase to volume, and mix.
          Calculation Calculate the content of C₁₁H₁₂Cl₂N₂O₅ in the portion of the Eye Ointment taken, using the declared content of C₁₁H₁₂Cl₂N₂O₅ in Chloramphenicol RS.

Other requirements Complies with the requirements described under “Eye Preparations” (Appendix 1.16).