Enantiomeric separation and impurity determination of valaciclovir hydrochloride / 浙江大学学报·医学版
Journal of Zhejiang University. Medical sciences
;
(6): 164-167, 2014.
Article
in Chinese
| WPRIM
| ID: wpr-336724
ABSTRACT
<p><b>OBJECTIVE</b>To determine the contents of L-enantiomer impurity in valaciclovir hydrochloride.</p><p><b>METHODS</b>Valaciclovir enantiomers were separated and determined by using chiral high performance liquid chromatography. Chromatographic conditions were as followsCROWNPAK(®) CR(+) chiral column (4 mm×150 mm, 5 μm), detection wavelength254 nm, mobile phasewater-methanol-perchloric acid (1910.1), flow rate0.75 ml/min, sample injection volume10 μl.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Stereoisomerism
/
Valine
/
Acyclovir
/
Chromatography, High Pressure Liquid
/
Methods
Language:
Chinese
Journal:
Journal of Zhejiang University. Medical sciences
Year:
2014
Type:
Article
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