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IDOXURIDINE EYE DROPS

Category Antiviral (ophthalmic).

      Idoxuridine Eye Drops are a sterile solution of Idoxuridine in Purified Water. They contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C9H11IN2O5.

Strength available 0.1 per cent w/v

Dose Keratitis, herpes simplex virus: Topical, to the conjunctiva, 1 drop every hour during the day and every 2 hours during the night; or 1 drop every minute for 5 minutes with the dosage schedule repeated every 4 hours day and night. Treatment should be continued until definite improvement occurs, as demonstrated by loss of staining with fluorescein. Dose may then be reduced to 1 drop every 2 hours during the day and every 4 hours during the night.

Warning; Precaution; Additional information See under Idoxuridine, p. 120.

Packaging and storage Idoxuridine Eye Drops shall be stored at a temperature between 2º and 8º, protected from light.

Labelling The label on the container states that they should not be used for continuous periods of treatment exceeding 21 days.

Identification

      A. Dilute a suitable volume of the eye drops with 0.01 M sodium hydroxide  to produce a solution containing 0.004 per cent w/v of idoxuridine: the ultraviolet absorption spectrum of the resulting solution, when observed between 230 nm and 350 nm, exhibits a maximum only at 279 nm (Appendix 2.2).

      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 4.5 to 7.0 (Appendix 4.11).

Related substances Carry out the test as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Chromatographic system Proceed as directed in the Assay.

      Mobile phase Prepare a mixture of 24 volumes of water and 1 volume of methanol.

      Reference solution Prepare the solution containing 4.0 μg per ml of 2’-deoxyuridine, 8.0 μg per ml of 5- iodouracil, 4.0 μg per ml of 5-bromo-2’-deoxyuridine and 1 μg per ml of sulfanilamide (internal standard).

      Test solution (a) Dilute a suitable volume of the eye drops with water to give a final concentration of 800 μg per ml of idoxuridine.

      Test solution (b) Dilute a suitable volume of the eye drops with sufficient of a suitable solution of sulfanilamide to give a final concentration of 800 μg per ml of idoxuridine and 1 μg per ml of sulfanilamide (internal standard).

      The order of elution of the peaks following the internal standard is deoxyuridine, iodouracil, bromodeoxyuridine, and idoxuridine. Several peaks due to excipients may appear in the chromatogram obtained from Test solution (b)  before the peak due to the internal standard.

      In the chromatogram obtained from Test solution (b), the ratios of the areas of any peaks due to 2’- deoxyuridine, 5-iodouracil and 5-bromo-2’- deoxyuridine to the area of the peak due to sulfanilamide are not greater than the ratios of the areas of the corresponding peaks in the chromatogram obtained from Reference solution.

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

      Mobile phase Prepare a mixture of 13 volumes of methanol and 87 volumes of water. Make adjustments if necessary.

      Internal standard solution Prepare a solution containing about 120 mg of sulfathiazole in 10.0 ml of ethanol, warming if necessary, and dilute to 100.0 ml with water.

      Standard preparation Shake about 100 mg of Idoxuridine RS, accurately weighed, with 50 ml of water until dissolved and then dilute to 100.0 ml with water and mix. To 15.0 ml of this solution add 2.0 ml of Internal standard solution, dilute to 20.0 ml with water, and mix.

      Assay preparation Dilute an accurately measured volume of Idoxuridine Eye Drops with water to obtain a solution containing about 1 mg per ml of idoxuridine. To 15.0 ml of this solution add 2.0 ml of Internal standard solution, dilute to 20.0 ml with water and mix.

      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, (b) Mobile phase at a flow rate of about 1.7 ml per minute, and (c) an ultraviolet photometer set at 254 nm.

      To determine the suitability of the chromatographic system, chromatograph Standard preparation 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 and Assay preparation into the chromatograph, record the chromatograms and measure the responses for the major peaks

      Calculation Calculate the content of C9H11IN2O5 in each ml of the Eye Drops taken, using the declared content of C9H11IN2O5 in Idoxuridine RS.

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

MONOGRAPHS • IDOXURIDINE EYE DROPS
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หมายเหตุ / Note : TP II 2011 PAGE 121 - 122