盐酸纳曲酮重金属检测方法及纳洛酮注射液含量测定.pdfVIP

3988Naloxone/MonographsUSP35

about100μgofnaloxonehydrochloride,toa10-mLvolumet-ideslowlyuntilnomorewhiteprecipitateisformed.Extract

ricflask,addDilutingsolventtovolume,andmix.withthree5-mLportionsofchloroform,filtertheextracts

Assaypreparation2(forInjectionlabeledtocontainmorethroughadryfilter,collectingthefiltrateinasmallflask.Evap-

than100μgofnaloxonehydrochloridepermL)—Transferanoratethefiltrateonasteambathtodryness,anddrytheresi-

accuratelymeasuredvolumeofInjection,equivalenttoaboutdueat105°foronehour.

2000μgofnaloxonehydrochloride,toa200-mLvolumetricSpecificrotation781S:ween−187°and−197°,calcu-

flask,addDilutingsolventtovolume,andmix.latedontheanhydrous,solvent-freebasis.

Systemsuitabilitypreparation—PrepareasolutioninDilutingTestsolution:25mgpermL,inwater.

solventcontainingabout20μgofUSPNaloxoneRSandaboutWater,MethodI921—Determinethewatercontentasdi-

2.5μgofacetaminophenpermL.rected.[NOTE—Theresultofthistestisusedinthecalculationof

Chromatographicsystem(seeChromatography621)—TheLimitoftotalsolvents.]

liquidchromatographisequippedwitha229-nmdetectorandResidueonignition281:notmorethan0.1%.

a4.6-mm×25-cmcolumnthatcontainspackingL1.