Application of pressurized liquid extraction technology to pharmaceutical solid dosage form analysis.
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 degrees C and a pressure of 1.0 x 10(4) kPa, to disintegrate the tablet, followed by three cycles of methanol for 3 min at 70 degrees C and 1.0 x 10(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.
Hoang
T H
TH
Department of Pharmaceutical Research and Development, Merck Frosst Canada & Co., Pointe Claire-Dorval, QC, Canada. thanh_hoang@merck.com
Farkas
R
R
Wells
C
C
McClintock
S
S
Di Maso
M
M
D002853:Chromatography, Liquid / Q000379:methods*; D004304:Dosage Forms; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D013696:Temperature
D004304:Dosage Forms; D004364:Pharmaceutical Preparations