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毛細(xì)管氣相色譜法測定注射用地西他濱中的殘留溶劑

發(fā)布時(shí)間:2018-02-02 19:57

  本文關(guān)鍵詞: 注射用地西他濱 殘留溶劑 毛細(xì)管氣相色譜法 出處:《中國藥房》2015年33期  論文類型:期刊論文


【摘要】:目的:建立測定注射用地西他濱中殘留溶劑的方法。方法:采用毛細(xì)管氣相色譜法,按內(nèi)標(biāo)法計(jì)算殘留溶劑的含量。色譜柱為Agilent DB-624毛細(xì)管柱,檢測器為氫火焰離子化檢測器,檢測器溫度為280℃,進(jìn)樣口溫度為230℃,柱溫采用程序升溫,載氣為高純氮,流速為1.5 ml/min,分流比為50∶1,進(jìn)樣方式為直接進(jìn)樣,進(jìn)樣量為1μl。結(jié)果:乙醇、乙醚、異丙醇、乙腈、二氯甲烷、四氫呋喃、環(huán)己烷、甲苯、N,N-二甲基甲酰胺的檢測質(zhì)量濃度線性范圍分別為0.100 3~2.507、0.101 3~2.532、0.102 2~2.556、0.008 3~0.207 8、0.012 4~0.309 3、0.014 8~0.369 4、0.078 1~1.953、0.024 9~1.250、0.017 6~0.440 9 mg/ml(r均≥0.999 2);精密度、重復(fù)性試驗(yàn)的RSD2%;加樣回收率為96.70%~101.60%,RSD為0.59%~1.82%(n=9)。結(jié)論:該方法簡便、準(zhǔn)確、重復(fù)性好,適用于注射用地西他濱中殘留溶劑的測定。
[Abstract]:Objective: to establish a method for the determination of residual solvents in descitabine injection. Methods: capillary gas chromatography was used. The content of residual solvent was calculated by internal standard method. The chromatographic column was Agilent DB-624 capillary column, the detector was hydrogen flame ionization detector, and the detector temperature was 280 鈩,

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