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[Enantiomeric Separation and Impurity Determination of Valaciclovir Hydrochloride]

Qian-ying Zhu, Lu-shan Yu, Guo-gang Zheng, Sheng-gu Xie, Qiao-feng Tao

Zhejiang Da Xue Xue Bao Yi Xue Ban. 2014 Mar;43(2):164-7.

PMID: 24782372

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 references.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
CS31043519 D-Valganciclovir D-Valganciclovir Price
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