Enantiomeric separation and impurity determination of valaciclovir hydrochloride
10.3785/j.issn.1008-9292.2014.03.008
- VernacularTitle:盐酸伐昔洛韦的手性分离及其对映体杂质的含量测定
- Author:
Qian-Ying ZHU
1
;
Lu-Shan YU
;
Guo-Gang ZHENG
;
Sheng-Gu XIE
;
Qiao-Feng TAO
Author Information
1. 浙江大学药学院药物分析与药物代谢研究室浙江省抗肿瘤药物临床前研究重点实验室
- Keywords:
Acyclovir/isolation & purification;
Acyclovir/analogs & derivatives;
Chromatography,high pressure liquid/methods;
Stereoisomerism
- From:
Journal of Zhejiang University. Medical sciences
2014;(2):164-167
- CountryChina
- Language:Chinese
-
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 .
