C19H22ClN5O·HCl 408.32
1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one,2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-,monohydrochloride.
2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]s-triazolo[4,3-a]-pyridin-3(2H)-one monohydrochloride [25332-39-2].
?Trazodone Hydrochloride contains not less than 97.0percent and not more than 102.0percent of C19H22ClN5O·HCl,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
USP Reference standards á11?— USP Trazodone Hydrochloride RS.
Identification— A: Infrared Absorption á197K?.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,both relative to the internal standard,as obtained in the Assay.
Loss on drying á731?— Dry it at a pressure of about 50mm of mercury at 105
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281?: not more than 0.2%.
Chromatographic purity—
Mobile phase— Prepare a filtered and degassed mixture of 0.5%trifluoroacetic acid,tetrahydrofuran,acetonitrile,and methanol (13.5:3:3:1).Make adjustments if necessary (see System Suitabilityunder Chromatography á621?).
Standard solution— Dissolve an accurately weighed quantity of USP Trazodone Hydrochloride RSin Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a known concentration of about 2μg per mL.
System suitability solution— Dissolve suitable quantities of 3-chloroaniline and USP Trazodone Hydrochloride RSin Mobile phaseto obtain a solution containing about 0.1mg per mLof 3-chloroaniline and 0.01mg per mLof trazodone hydrochloride,respectively.
Test solution— Transfer about 50mg of trazodone hydrochloride,accurately weighed,to a 50-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and filter
