Tinidazole
;)
1H-Imidazole,1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-.
1-[2-(Ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole [19387-91-8].
»Tinidazole contains not less than 98.0percent and not more than 101.0percent of C8H13N3O4S,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers,protected from light,at controlled room temperature.
USP Reference standards á11ñ—
USP Tinidazole RS.USP Tinidazole Related Compound A RS.USP Tinidazole Related Compound B RS.
Identification—
A:Infrared Absorption á197Kñ.
C:
The RFvalue and intensity of the principal spot obtained from the chromatogram of Test solution 2correspond to those obtained from the chromatogram of Standard solution 1,as obtained in the test for Related compounds.
Loss on drying á731ñ—
Dry it at a temperature between 100
and 105to constant weight:it loses not more than 0.5%of its weight.
and 105to constant weight:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method IIá231ñ:
0.002%.
Related compounds—
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture.
Test solution 1—
Dissolve about 200mg of Tinidazole,accurately weighed,in 10mLof methanol.
Test solution 2—
Transfer 1.0mLof Test solution 1to a 10-mLvolumetric flask,dilute with methanol to volume,and mix.
Standard solution 1—
Prepare a solution of USP Tinidazole RSin methanol containing 2.0mg per mL.
Standard solution 2—
Dilute 1.0mLof Standard solution 1with methanol to 20mL.
Standard solution 3—
Dilute 4.0mLof Standard solution 2with methanol to 10mL.
Standard solution 4—
Prepare a solution of USP Tinidazole Related Compound A RSin methanol containing 0.1mg per mL.
Standard solution 5—
Prepare a solution of USP Tinidazole Related Compound B RSin methanol containing 0.1mg per mL.
Application volume:
10µL.
Developing solvent system:
a mixture of ethyl acetate and butyl alcohol (3:1).
Procedure—
Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñ.Activate the plate for at least 1hour at 110.Examine the plate under short-wavelength UVlight:any spots due to tinidazole related compound Aand tinidazole related compound Bobtained from Test solution 1are no more intense than the corresponding spots obtained from Standard solution 4and Standard solution 5,respectively;any spot,other than the principal spot,obtained from Test solution 1is not more intense than the spot obtained from Standard solution 2;and not more than one such spot is more intense than the spot obtained from Standard solution 3.
.Examine the plate under short-wavelength UVlight:any spots due to tinidazole related compound Aand tinidazole related compound Bobtained from Test solution 1are no more intense than the corresponding spots obtained from Standard solution 4and Standard solution 5,respectively;any spot,other than the principal spot,obtained from Test solution 1is not more intense than the spot obtained from Standard solution 2;and not more than one such spot is more intense than the spot obtained from Standard solution 3.
Assay—
Dissolve 150mg of Tinidazole,accurately weighed,in 25.0mLof glacial acetic acid,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically with suitable electrodes (see Titrimetry á541ñ).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 24.73mg of C8H13N3O4S.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1936
Pharmacopeial Forum:Volume No.27(1)Page 1820
Phone Number:1-301-816-8394