DFS method changes scale down sample volume and remove methylene chloride from LC–MS quantitation method
DFS proposed and the subcommittee approved method updates that replace methylene chloride (per EPA restrictions), reduce sample volume from 1.0 mL to 250 µL, change SPE bed mass, and alter internal‑standard choices; members asked DFS to soften language calling the changes 'slight.'
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Dr. Wagner presented method‑development and validation plans for miscellaneous basic drug quantitation and confirmation by LC‑MS. The proposed changes include removing methylene chloride in response to EPA restrictions, changing elution solvent to an ethyl‑acetate/acetonitrile/ammonium‑hydroxide mix, reducing sample volume from 1.0 mL to 250 µL, and decreasing SPE bed mass from 200 mg to 50 mg; the presenter also noted steps taken to limit amitriptyline→nortriptyline conversion and internal‑standard adjustments.
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