摘要
目的：了解国产盐酸伐昔洛韦中L-对映体杂质的含量，为我国药典制订手性药物杂质限量提供参考数据。方法：应用手性高效液相色谱法。色谱条件：CROWNPAK？ CR（＋）手性柱（4 mm ×150 mm，5μm）；检测器波长254 nm；流动相为水-甲醇-高氯酸（19∶1∶0．1）；流速0．75 ml/min，进样量10μl。结果：D-伐昔洛韦与L-伐昔洛韦完全分离，分离度为12。不同厂家的8批盐酸伐昔洛韦中L-对映体杂质的平均含量为0．65％～2．62％。结论：各批产品中L-对映体杂质含量均符合美国药典标准，我国药典可以参照此数据。
Objective： To determine the contents of L-enantiomer impurity in valaciclovir hydrochloride .Methods： Valaciclovir enantiomers were separated and determined by using chiral high performance liquid chromatography .Chromatographic conditions were as follows：CROWNPAK ？CR （＋） chiral column （4 mm ×150 mm,＆nbsp;5 μm）, detection wavelength：254 nm, mobile phase： water-methanol-perchloric acid （19∶1∶0.1）, flow rate：0.75 ml/min, sample injection volume：10 μl.Results： D-valaciclovir was completely separated from L-enantiomer impurity .The contents of L-enantiomer impurity were 0 .65%-2 .62% on average in 8 batches of valaciclovir hydrochloride .Conclusion： Enantiomeric impurity contents in each batch of products were all meet criteria of United States Pharmacopeia , which can be used in criteria of Chinese Pharmacopeia as refenences .
出处
《浙江大学学报（医学版）》
CAS
CSCD
北大核心
2014年第2期164-167,共4页
Journal of Zhejiang University(Medical Sciences)
基金
国家药典委员会科研基金(20120820)
国家重点基础研究发展计划(973计划)(2011CB710800)
