卡培他滨的定性鉴别与定量测定

Qualitative identification and quantitative determination of capecitabine

卡培他滨的定性鉴别与定量测定是保证该药安全、有效、质量可控的基础和前提。为了使卡培他滨定性鉴别与定量测定结果准确、可靠,建立了红外分光光度法、旋光度测定法、高效液相色谱法、X射线衍射法、同步热分析法、有机氟化物的鉴别反应和化学分析滴定法等7种测定卡培他滨质量分数的方法,实现多角度、多层面方法验证,进而达到控制药品质量的目的。

The qualitative identification and quantitative determination of capecitabine can ensure the product to meet prescribed standards of safety,efficiency and controllable quality.For the purposes of gaining accurate and reliable results from qualitative identification and quantitative determination of capecitabin,seven alternative determination methods for capecitabine are established,such as IR spectrophotometry,optical rotation,high performance liquid chromatography,X-ray diffraction,simultaneous thermal analysis,differential reaction of organic fluorides and chemical analysis titration.Through multi angle and multi-layer verification,the goal of controlling drug quality can be achieved.