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Category Antifungal (vaginal).

          Clotrimazole Vaginal Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of C₂₂H₁₇ClN₂.

Strengths available 100 and 500 mg.

Dose Adults: Insert one 100-mg tablet intravaginally at bedtime for 7 nights or two 100-mg tablets intravaginally at bedtime for 3 nights or insert one 500-mg tablet intravaginally once only, preferably at bedtime.

Contra-indication; Warning; Precaution; Additional information See under Clotrimazole, p. 83.

Identification
          A. Comply with the tests for Identification A described under Clotrimazole Cream, p. 67. For solution (A), transfer a portion of the powdered tablets, containing 50 mg of clotrimazole, in a screw-capped 50-ml centrifuge tube. Add 10 ml of chloroform, shake vigorously for about 2 minutes and centrifuge to obtain a clear chloroform phase. (Note The supernatant liquid may remain slightly turbid.)
          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.

(2-Chlorophenyl)diphenylmethanol Not more than 1 per cent. Carry out the test as described in the Highpressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Diluting solution, Reference solution and Procedure Proceed as directed in the (2- Chlorophenyl)diphenylmethanol under Clotrimazole Cream, p. 85.
          Test solution (a) Transfer a portion of the powdered vaginal tablets, containing 100 mg of clotrimazole to a 100-ml volumetric flask. Add 50 ml of methanol and shake for 20 minutes. Dilute to volume with methanol and filter. To 20.0 ml of the filtrate add 50 ml of methanol and sufficient 0.02 M phosphoric acid to produce 100.0 ml.
          Test solution (b) Dilute 1 volume of Test solution (a) to 50 volumes with Diluting solution.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay under Clotrimazole Cream, p. 85.
          Assay preparation Weigh and finely powder not less than 20 Clotrimazole Vaginal Tablets. Transfer an accurately weighed portion of the powder, containing about 100 mg of clotrimazole, to a 250-ml volumetric flask. Add 50 ml of methanol and shake for 20 minutes. Dilute to volume with methanol and filter. To 10.0 ml of the filtrate add 60 ml of methanol and sufficient 0.02 M phosphoric acid to produce 100.0 ml.
          Calculation Calculate the content of C₂₂H₁₇ClN₂ in the portion of the Tablets taken, using the declared content of C₂₂H₁₇ClN₂ in Clotrimazole RS.

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