Application of pressurized liquid extraction technology to pharmaceutical solid dosage form analysis

被引:14
作者
Hoang, TH [1 ]
Farkas, R [1 ]
Wells, C [1 ]
McClintock, S [1 ]
Di Maso, M [1 ]
机构
[1] Merck Frosst Canada & Co, Dept Pharmaceut Res & Dev, Pointe Claire, PQ H9R 4P8, Canada
关键词
pressurized liquid extraction; extraction method; pharmaceutical analysis; montelukast sodium;
D O I
10.1016/S0021-9673(02)00956-1
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
The technique of pressurized liquid extraction has been evaluated for the extraction of active ingredients from pharmaceutical dosage forms using montelukast sodium oral chewable tablets as a model. The extraction method was optimized for the number of extraction cycles, extraction time, extraction solvent composition and temperature. Samples were extracted using two cycles of water for 2 min with a cell temperature of 40 degreesC and a pressure of 1.0x10(4) kPa, to disintegrate the tablet, followed by three cycles of methanol for 3 min at 70 degreesC and 1.0x10(4) kPa, to solubilize montelukast sodium. The method demonstrated an extraction efficiency of 98.2% of label claim and an RSD of 1.3% (n=10), as compared to 97.6% and an RSD of 0.9% obtained using a validated mechanical extraction method. (C) 2002 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:257 / 261
页数:5
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