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
em Zh
| WPRIM
| ID: wpr-336724
Biblioteca responsável:
WPRO
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 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.</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>
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Base de dados:
WPRIM
Assunto principal:
Estereoisomerismo
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Valina
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Aciclovir
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Cromatografia Líquida de Alta Pressão
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Métodos
Idioma:
Zh
Revista:
Journal of Zhejiang University. Medical sciences
Ano de publicação:
2014
Tipo de documento:
Article