[Enantiomeric separation and impurity determination of valaciclovir hydrochloride].
To determine the contents of L-enantiomer impurity in valaciclovir hydrochloride.



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.



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.



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 references.
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.
Qian-ying
QY
Zhu
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.
Lu-shan
LS
Yu
Zhejiang Institute for Food and Drug Quality Control, Hangzhou.
Guo-gang
GG
Zheng
Zhejiang Institute for Food and Drug Quality Control, Hangzhou.
Sheng-gu
SG
Xie
Zhejiang Center for Drug Evaluation, Hangzhou 310012, China.
Qiao-feng
QF
Tao
D000212:Acyclovir / Q000031:analogs & derivatives* / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D013237:Stereoisomerism; D000077483:Valacyclovir; D014633:Valine / Q000031:analogs & derivatives* / Q000032:analysis
D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir