Abstract:
:Organic compounds extracted into metered dose inhalers (MDIs) from the rubber components of the metering valve are of increasing interest in the development of these formulations. Polycyclic aromatic hydrocarbons (PAHs) are a class of extractable organic compounds whose source is the carbon black commonly used as a reinforcing agent in rubber. The analytical method for PAHs described in this report employs "cold filtration" to remove the suspended drug substance and excipients, and gas chromatography/mass spectrometry (GC/MS) for separation and detection of individual PAHs. After filtration, stable isotope labelled analogues of target PAHs are spiked into the drug product to act as internal standards, correcting for recovery (termed "isotope dilution GC/MS"). Validation of the method was accomplished with respect to linearity, precision, limit of detection/quantitation, selectivity and ruggedness. Application to a variety of MDI drug product formulations revealed that certain PAHs are present at the ng/inhaler level.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Norwood DL,Prime D,Downey BP,Creasey J,Sethi SK,Haywood Pdoi
10.1016/0731-7085(95)01273-nsubject
Has Abstractpub_date
1995-03-01 00:00:00pages
293-304issue
3eissn
0731-7085issn
1873-264Xpii
0731-7085(95)01273-Njournal_volume
13pub_type
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