title: Microwave-assisted extraction of active pharmaceutical ingredient from solid dosage forms.
abstract: The microwave assisted extraction (MAE) technique has been evaluated for the extraction of active pharmaceutical ingredients (API) from various solid dosage forms. Using immediate release tablets of Compound A as a model, optimization of the extraction method with regards to extraction solvent composition, extraction time and temperature was briefly discussed. Complete recovery of Compound A was achieved when samples were extracted using acetonitrile as the extraction solvent under microwave heating at a constant cell temperature of 50 degrees C for 5 min. The optimized MAE method was applied for content uniformity (single tablet extraction) and potency (multiple tablets extraction) assays of release and stability samples of two products of Compound A (5 and 25mg dose strength) stored at various conditions. To further demonstrate the applicability of MAE, the instrumental extraction conditions (50 degrees C for 5 min) were adopted for the extraction of montelukast sodium (Singulair) from various solid dosage forms using methanol-water (75:25, v/v) as the extraction solvent. The MAE procedure demonstrated an extraction efficiency of 97.4-101.9% label claim with the greatest RSD at 1.4%. The results compare favorably with 97.6-102.3% label claim with the greatest RSD at 2.9% obtained with validated mechanical extraction procedures. The system is affordable, user-friendly and simple to operate and troubleshoot. Rapid extraction process (7 min/run) along with high throughput capacity (up to 23 samples simultaneously) would lead to reduced cycle time and thus increased productivity.
authors.affiliation: Department of Pharmaceutical Research and Development, Merck Frosst Canada Ltd., Pointe Claire-Dorval, Quebec, Canada. thanh_hoang@merck.com
authors.forename: T H
authors.initials: TH
authors.lastname: Hoang
authors.forename: R
authors.initials: R
authors.lastname: Sharma
authors.forename: D
authors.initials: D
authors.lastname: Susanto
authors.forename: M
authors.initials: M
authors.lastname: Di Maso
authors.forename: E
authors.initials: E
authors.lastname: Kwong
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D004987:Ethers / Q000032:analysis / Q000302:isolation & purification; D006845:Hydrocarbons, Fluorinated / Q000032:analysis / Q000302:isolation & purification; D008872:Microwaves; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013696:Temperature
chemical_list: D004304:Dosage Forms; D004987:Ethers; D006845:Hydrocarbons, Fluorinated; D004364:Pharmaceutical Preparations; C078742:fluoromethyl 2,2-difluoro-1-(trifluoromethyl)vinyl ether