Clotrimazole Vaginal Inserts
(Monograph under this new title—to become official October 1,2005)
(Current monograph title is Clotrimazole Vaginal Tablets)
»Clotrimazole Vaginal Inserts contain not less than 90.0percent and not more than 110.0percent of the labeled amount of clotrimazole (C22H17ClN2).
Packaging and storage— Preserve in well-closed containers.
Identification— Place an amount of finely powdered Vaginal Inserts,equivalent to about 50mg of clotrimazole,in a screw-capped,50-mLcentrifuge tube.Add 10mLof chloroform,and shake vigorously for about 2minutes.Centrifuge to clarify.[NOTE—The supernatant may remain slightly turbid.]Proceed as directed in the Identificationtest under Clotrimazole Cream,except to use a Standard solution of USP Clotrimazole RSin chloroform containing 5mg per mL.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Dibasic potassium phosphate solution andMobile phase— Prepare as directed in the Assayunder Clotrimazole.
Internal standard solution,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Clotrimazole Topical Solution.
Assay preparation— Weigh and finely powder not fewer than 10Vaginal Inserts.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of clotrimazole,to a 50-mL,screw-capped centrifuge tube,add 10.0mLof Internal standard solutionand 15mLof Mobile phase,rotate for 15minutes,and centrifuge for 10minutes.Using a suitable syringe,transfer the supernatant to a 100-mLvolumetric flask.Rinse the syringe with 25mLof Mobile phase,adding the rinsings to the centrifuge tube.Rotate the centrifuge tube for 15minutes,and centrifuge for 10minutes.Using a suitable syringe,transfer the supernatant to the 100-mLvolumetric flask.Rinse the syringe with 25mLof Mobile phase,and add the washings to the 100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of clotrimazole (C22H17ClN2)in the portion of Vaginal Inserts taken by the formula:
100C(RU/RS),
in which Cis the concentration,in mg per mL,of USP Clotrimazole RSin the Standard preparation;and RUand RSare the peak response ratios of clotrimazole to testosterone propionate obtained from the Assay preparationand the Standard preparation,respectively.
(Official October 1,2005)
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 523
Pharmacopeial Forum:Volume No.29(3)Page 623
Phone Number:1-301-816-8394
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