Short-end injection technique in capillary electrophoresis for dissolution testing of tablets

被引:17
作者
Blanchin, MD
Baalbaki, B
Bosc, N
Fabre, H [1 ]
机构
[1] Fac Pharm Montpellier, Chim Analyt Lab, F-34060 Montpellier 2, France
[2] Lipha SA, F-69003 Lyon, France
关键词
capillary electrophoresis (CE); short-end injection; liquid chromatography; comparison; dissolution testing; tablets;
D O I
10.1016/S0003-2670(00)00852-7
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A capillary electrophoresis (CE) method using short-end injection technique has been developed for dissolution testing of tablets of calcium acamprosate. After dilution of dissolution bath sample solution (in 0.1 M citric acid) in water, the sample (11.5 nl) was injected on the detector side in a fused silica capillary 31.2 cm long (21 cm to the detector) x 50 mu m internal diameter. Acamprosate was separated from sorbate (internal standard) in a 50 mM berate buffer solution applying a 500 V cm(-1) electric field. The compounds were detected at 200 nm, Relative corrected peak areas (acamprosate/sorbate) were used for quantitation. The method was shown to be specific (versus tablet excipients), linear (r(2)>0.999), accurate (average recovery of 100.3% obtained by three analysts on 3 days at five levels) and repeatable (RSD<1%). The limits of detection and quantification corresponded, respectively, to 0.8 and 2.5% of drug released. Good agreement was found between the results obtained by the CE method and a liquid chromatography (LC) method with ion-pairing (maximum difference of 1.7% relative to the LC results), for sample solutions withdrawn from the dissolution bath. CE presents the advantage of being more rapidly set-up and executed than LC (4 versus 12 min). (C) 2000 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:67 / 73
页数:7
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