title: Identification of Drugs in Parenteral Pharmaceutical Preparations from a Quality Assurance and a Diversion Program by Direct Analysis in Real-Time AccuTOFTM-Mass Spectrometry (DART-MS).
abstract: In healthcare settings drug diversion and impairment of physicians are major concerns requiring a rapid and efficient method for surveillance and detection. A Direct Analysis in Real Time ion source coupled to a JEOL AccuTOFTMtime-of-flight mass spectrometer (DART-MS) method was developed to screen parenteral pharmaceutical formulations for potential drug diversion. Parenteral pharmaceutical formulations are also known as injectable formulations and are used with intravenous, subcutaneous, intramuscular and intra-articular administration. A library was created using the mass spectra data collected by a DART-MS operated in switching mode at 20, 60 and 90 V settings. This library contained 17 commonly encountered drugs in parenteral pharmaceutical formulations that included the surgical analgesic: fentanyl, hydromorphone and morphine; anesthetic: baclofen, bupivacaine, ketamine, midazolam, ropivacaine and succinylcholine; and a mixture of other drug classes: caffeine, clonidine, dexamethasone, ephedrine, heparin, methadone, oxytocin and phenylephrine. Randomly selected 200 de-identified parenteral pharmaceutical formulations containing one or more drugs were submitted for analysis to the FIRM Toxicology Laboratory at Virginia Commonwealth University Health and were screened using the DART-MS. The drug contents of the de-identified formulations were previously confirmed by a published high performance liquid chromatography (HPLC) method. The drugs in the formulations were rapidly and successfully identified using the generated library. The DART-MS and HPLC results were in complete agreement for all 200 parenteral pharmaceutical formulations.
authors.affiliation: Department of Pharmacology & Toxicology, Virginia Commonwealth University, Richmond, VA 23298-0613, USA justin.poklis@vcuhealth.org.
authors.forename: Justin L
authors.initials: JL
authors.lastname: Poklis
authors.affiliation: Department of Forensic Science, Virginia Commonwealth University, Richmond, VA 23284-3079, USA.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Mohs
authors.affiliation: Department of Forensic Science, Virginia Commonwealth University, Richmond, VA 23284-3079, USA Department of Pathology, Virginia Commonwealth University, Richmond, VA 23298-0165, USA.
authors.forename: Carl E
authors.initials: CE
authors.lastname: Wolf
authors.affiliation: Department of Pharmacology & Toxicology, Virginia Commonwealth University, Richmond, VA 23298-0613, USA Department of Forensic Science, Virginia Commonwealth University, Richmond, VA 23284-3079, USA Department of Pathology, Virginia Commonwealth University, Richmond, VA 23298-0165, USA.
authors.forename: Alphonse
authors.initials: A
authors.lastname: Poklis
authors.affiliation: Department of Forensic Science, Virginia Commonwealth University, Richmond, VA 23284-3079, USA.
authors.forename: Michelle R
authors.initials: MR
authors.lastname: Peace
mesh_terms: D000577:Amides / Q000032:analysis; D000700:Analgesics / Q000032:analysis*; D000777:Anesthetics / Q000032:analysis; D001418:Baclofen / Q000032:analysis; D002045:Bupivacaine / Q000032:analysis; D002110:Caffeine / Q000032:analysis; D002851:Chromatography, High Pressure Liquid; D003000:Clonidine / Q000032:analysis; D003907:Dexamethasone / Q000032:analysis; D004809:Ephedrine / Q000032:analysis; D005283:Fentanyl / Q000032:analysis; D006493:Heparin / Q000032:analysis; D004091:Hydromorphone / Q000032:analysis; D007649:Ketamine / Q000032:analysis; D013058:Mass Spectrometry / Q000379:methods*; D008691:Methadone / Q000032:analysis; D008874:Midazolam / Q000032:analysis; D009020:Morphine / Q000032:analysis; D010121:Oxytocin / Q000032:analysis; D057947:Parenteral Nutrition Solutions / Q000032:analysis*; D010656:Phenylephrine / Q000032:analysis; D000077212:Ropivacaine; D013390:Succinylcholine / Q000032:analysis
chemical_list: D000577:Amides; D000700:Analgesics; D000777:Anesthetics; D057947:Parenteral Nutrition Solutions; D010656:Phenylephrine; D002110:Caffeine; D010121:Oxytocin; D007649:Ketamine; D009020:Morphine; D000077212:Ropivacaine; D003907:Dexamethasone; D006493:Heparin; D004809:Ephedrine; D001418:Baclofen; D013390:Succinylcholine; D003000:Clonidine; D004091:Hydromorphone; D008874:Midazolam; D008691:Methadone; D005283:Fentanyl; D002045:Bupivacaine