Trichlormethiazide Tablets, chemical structure, molecular formula, Reference Standards
»Trichlormethiazide Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C8H8Cl3N3O4S2.
Packaging and storage
Preserve in tight containers.
USP Reference standards á11ñ
USP Trichlormethiazide RS.
Evaporate 25mLof the combined ethyl acetate extracts obtained in the Assayon a steam bath to dryness,and dissolve the residue in 1mLof a mixture of equal volumes of benzene and alcohol:a 10-µLportion of this solution responds to Identificationtest Bunder Trichlormethiazide.
[NOTEConduct the analysis of the specimen promptly after the specimen aliquot is withdrawn from the vessel,to minimize hydrolysis.]Determine the amount of C8H8Cl3N3O4S2dissolved,employing the procedure set forth in the Assay,making any necessary volumetric adjustments.
Not less than 65%(Q)of the labeled amount of C8H8Cl3N3O4S2is dissolved in 60minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
and Chromatographic systemPrepare as directed in the Assayunder Trichlormethiazide.
Add 2.8mLof sulfuric acid to 100mLof water,mix,and cool.Dilute with methanol to 1000mL,and mix.
Internal standard solution
Transfer about 20mg of methylparaben to a 200-mLvolumetric flask,add Acidic methanolto volume,and mix.
Transfer about 20mg of USP Trichlormethiazide RS,accurately weighed,to a 50-mLvolumetric flask,add Acidic methanolto volume,and mix.Transfer 5.0mLof this solution to a centrifuge tube,add 5.0mLof Internal standard solution,and mix to obtain a solution having a known concentration of about 0.2mg of USP Trichlormethiazide RSper mL.
Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to 2mg of trichlormethiazide,to a centrifuge tube.Add 5.0mLof Acidic methanoland 5.0mLof Internal standard solution,and mix to disperse the powder.Insert the stopper in the tube,rotate by mechanical means for 20minutes,and centrifuge to obtain a clear supernatant.
Separately inject equal volumes (5µLto 25µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.The relative retention times are about 0.58for trichlormethiazide and 1.0for methylparaben.Calculate the quantity,in mg,of C8H8Cl3N3O4S2in the portion of Tablets taken by the formula:
in which Cis the concentration,in mg per mL,of USP Trichlormethiazide RSin the Standard preparation,and RUand RSare the peak response ratios obtained from the Assay preparationand the Standard preparation,respectively.
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
信息录入：awin 责任编辑：awin 【发表评论