ENANTIOMERIC PURITY DETERMINATION OF PROPRANOLOL BY CYCLODEXTRIN-MODIFIED CAPILLARY ELECTROPHORESIS

被引：87

作者：

FILLET, M ^{[1
]}

BECHET, I ^{[1
]}

CHIAP, P ^{[1
]}

HUBERT, P ^{[1
]}

CROMMEN, J ^{[1
]}

机构：

[1] UNIV LIEGE,INST PHARM,DRUG ANAL LAB,B-4000 LIEGE,BELGIUM

来源：

JOURNAL OF CHROMATOGRAPHY A | 1995年 / 717卷 / 1-2期

关键词：

D O I：

10.1016/0021-9673(95)00503-6

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A capillary electrophoretic method for the enantiomeric purity determination of either enantiomer of propranolol was developed using cyclodextrins as chiral additives and uncoated fused-silica capillaries thermostated at 15 degrees C. The effect of the type and concentration of cyclodextrin added to a triethanolamine-phosphate buffer (pH 3.0) on chiral resolution and migration times was studied. The propranolol enantiomers could be separated with all cyclodextrins tested (P-cyclodextrin and seven of its derivatives), except dimethyl-P-cyclodextrin. A particularly high resolution value of 4.4 was obtained for propranolol enantiomers with a buffer containing 10 mM carboxymethyl-beta-cyclodextrin. This buffer was selected for testing the enantiomeric purity of propranolol, making it possible to reach detection limits of less than 0.1% for the minor enantiomer. The R enantiomer of propranolol (second migrating) could be quantified at the 0.5% level with good precision (intra-day R.S.D. = 1.7%) in samples of the S enantiomer (first migrating), while the limit of quantification of the latter, when present as an impurity in the R enantiomer, was 0.1%. The method also gave good results in terms of linearity and accuracy.

引用

页码：203 / 209

页数：7

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