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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>
Subject(s)
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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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