Analysis of polycyclic aromatic hydrocarbons in metered dose inhaler drug formulations by isotope dilution gas chromatography/mass spectrometry
| Autor: | Daniel L. Norwood, David Prime, Brian P. Downey, Jason Creasey, Satinder K. Sethi, Phil Haywood |
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| Rok vydání: | 1995 |
| Předmět: |
Detection limit
Radioisotope Dilution Technique Chromatography Stable isotope ratio Chemistry Nebulizers and Vaporizers Clinical Biochemistry Pharmaceutical Science Isotope dilution Reference Standards Mass spectrometry Metered-dose inhaler Gas Chromatography-Mass Spectrometry Analytical Chemistry law.invention Solutions law Drug Discovery Indicators and Reagents Polycyclic Compounds Gas chromatography Gas chromatography–mass spectrometry Spectroscopy Filtration |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 13(3) |
| ISSN: | 0731-7085 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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