Enantiomeric separation and impurity determination of valaciclovir hydrochloride.

Qian-ying Zhu; Lu-shan YU; Guo-gang Zheng; Sheng-gu Xie; Qiao-feng Tao

Return

Enantiomeric separation and impurity determination of valaciclovir hydrochloride.

Author: Qian-ying ZHU ^{1
,

2} ; Lu-shan YU ¹ ; Guo-gang ZHENG ³ ; Sheng-gu XIE ³ ; Qiao-feng TAO ⁴
Author Information

1. Laboratory of Pharmaceutical Analysis and Drug Metabalism, College of Pharmaceutical Sciences
2. Zhejiang Provincial Key Laboratory of Anti-Cancer Drug Research, Zhejiang University, Hangzhou 310058, China.
3. Zhejiang Institute for Food and Drug Quality Control, Hangzhou.
4. Zhejiang Center for Drug Evaluation, Hangzhou 310012, China.
Publication Type:Journal Article
MeSH: Acyclovir; analogs & derivatives; analysis; Chromatography, High Pressure Liquid; methods; Stereoisomerism; Valine; analogs & derivatives; analysis
From: Journal of Zhejiang University. Medical sciences 2014;43(2):164-167
CountryChina
Language:Chinese
Abstract:
OBJECTIVETo determine the contents of L-enantiomer impurity in valaciclovir hydrochloride.
METHODSValaciclovir 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.
RESULTSD-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.
CONCLUSIONEnantiomeric 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 references.