Application of pressurized liquid extraction technology to pharmaceutical solid dosage form analysis |
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Authors: | Hoang T H Farkas R Wells C McClintock S Di Maso M |
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Affiliation: | Department of Pharmaceutical Research and Development, Merck Frosst Canada & Co., Pointe Claire-Dorval, QC, Canada. thanh_hoang@merck.com |
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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. |
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