title: Evaluating the utility of ion mobility separation in combination with high-pressure liquid chromatography/mass spectrometry to facilitate detection of trace impurities in formulated drug products.
abstract: Many formulated products contain complex polymeric excipients such as polyethylene glycols (PEGs). Such excipients can be readily ionized by electrospray and may be present at very high concentrations, thus making it very difficult to identify trace level impurities such as degradants in samples, even if hyphenated techniques such as liquid chromatography/mass spectrometry (LC/MS) are used. Ion mobility (IM) spectrometry is a very rapid gas-phase separation technique and offers additional separation capability within the LC timeframe. This work investigates the use of an IM separator in combination with high-pressure liquid chromatography (HPLC) and MS, to improve the separation of drug-related materials from excipients, thus aiding the identification of trace-level impurities in an anti-HIV medication, Combivir.
authors.affiliation: GlaxoSmithKline, Analytical Sciences, Medicines Research Centre, Gunnels Wood Road, Stevenage SG1 2NY, UK. christine_2_eckers@gsk.com
authors.forename: Christine
authors.initials: C
authors.lastname: Eckers
authors.forename: Alice M-F
authors.initials: AM
authors.lastname: Laures
authors.forename: Kevin
authors.initials: K
authors.lastname: Giles
authors.forename: Hilary
authors.initials: H
authors.lastname: Major
authors.forename: Steve
authors.initials: S
authors.lastname: Pringle
mesh_terms: D019380:Anti-HIV Agents / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004338:Drug Combinations; D004340:Drug Contamination / Q000517:prevention & control*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D019259:Lamivudine / Q000737:chemistry*; D008832:Microchemistry / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods; D015215:Zidovudine / Q000737:chemistry*
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; C109078:lamivudine, zidovudine drug combination; D019259:Lamivudine; D015215:Zidovudine