Analysis of polycyclic aromatic hydrocarbons in metered dose inhaler drug formulations by isotope dilution gas chromatography/mass spectrometry.

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 Anal

authors

Norwood DL,Prime D,Downey BP,Creasey J,Sethi SK,Haywood P

doi

10.1016/0731-7085(95)01273-n

subject

Has Abstract

pub_date

1995-03-01 00:00:00

pages

293-304

issue

3

eissn

0731-7085

issn

1873-264X

pii

0731-7085(95)01273-N

journal_volume

13

pub_type

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