title: Application of pressurized liquid extraction technology to pharmaceutical solid dosage form analysis.
abstract: 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.
authors.affiliation: Department of Pharmaceutical Research and Development, Merck Frosst Canada & Co., Pointe Claire-Dorval, QC, Canada. thanh_hoang@merck.com
authors.forename: T H
authors.initials: TH
authors.lastname: Hoang
authors.forename: R
authors.initials: R
authors.lastname: Farkas
authors.forename: C
authors.initials: C
authors.lastname: Wells
authors.forename: S
authors.initials: S
authors.lastname: McClintock
authors.forename: M
authors.initials: M
authors.lastname: Di Maso
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D004304:Dosage Forms; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D013696:Temperature
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations