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Journal of ZheJiang University(Medical Science)  2014, Vol. 43 Issue (2): 164-167    DOI: 10.3785/j.issn.1008-9292.2014.03.008
    
Enantiomeric separation and impurity determination of valaciclovir hydrochloride
ZHU Qian-ying1, YU Lu-shan1, ZHENG Guo-gang2, XIE Sheng-gu2, TAO Qiao-feng3
1. Laboratory of Pharmaceutical Analysis and Drug Metabalism, College of Pharmaceutical Sciences; Zhejiang Provincial Key Laboratory of Anti-Cancer Drug Research, Zhejiang University, Hangzhou 310058, China; 2. Zhejiang Institute for Food and Drug Quality Control, Hangzhou 310004, China; 3. Zhejiang Center for Drug Evaluation, Hangzhou 310012, China
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Abstract  

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, 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.



Key wordsAcyclovir/ isolation &      purification      Acyclovir/ analogs &      derivatives      Chromatography, high pressure liquid/methods      Stereoisomerism     
Received: 11 October 2013     
Corresponding Authors: TAO Qiao-feng, E-mail: taoqiaofeng@126.com   
Cite this article:

ZHU Qian-ying, YU Lu-shan, ZHENG Guo-gang, XIE Sheng-gu, TAO Qiao-feng. Enantiomeric separation and impurity determination of valaciclovir hydrochloride. Journal of ZheJiang University(Medical Science), 2014, 43(2): 164-167.

URL:

http://www.zjujournals.com/xueshu/med/10.3785/j.issn.1008-9292.2014.03.008     OR     http://www.zjujournals.com/xueshu/med/Y2014/V43/I2/164


盐酸伐昔洛韦的手性分离及其对映体杂质的含量测定

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10 μl。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。


关键词: 阿昔洛韦/分离和提纯,  阿昔洛韦/类似物和衍生物,  色谱法,  高压液相/方法,  立体异构现象 
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