Pharma Science

Determination of Leachables in Orally Inhaled and Nasal Drug Products (OINDP) by GC/MS-MS

Shimadzu has produced an application note describing a highly sensitive method for the quantitation of 40 leachables in OINDP products by GC/MS-MS.

Shimadzu_MIC_determination-of-leachables.pngIntroduction
OINDP are developed for treating asthma or chronic obstructive pulmonary diseases by delivering drug substances directly to the respiratory tract. Some of the inhaled drug products are by far the most pharmacologically effective substances that are administered to humans. Drugs are present in OINDP devices, which may contain polymers, elastomers and other components from which minute quantities of material may migrate/leach into product and enter the respiratory tract along with the therapeutic agent.
Among those leachables, nitrosamines, phthalates and poly aromatic hydrocarbons (PAH) were targeted in this study due to their toxicity and carcinogenicity at low concentration levels.

As a result, a highly sensitive method was developed for the quantitation of 40 leachables in OINDP products using the Shimadzu GCMS-TQ8040. The method can be used for screening of leachables in various pharmaceutical products.

GCMS-TQ8040.pngKey features of GCMS-TQ8040

  • ASSP™ (Advanced Scanning Speed Protocol) enables high-speed scan and data acquisition for accurate quantitation at 20,000 u/sec.
  • Capable of performing simultaneous Scan/MRM.
  • UFsweeper® technology efficiently sweeps residual ions from the collision cell for fast, efficient ion
    transport ensuring no cross-talk.
  • Two overdrive lenses reduce random noise from helium, high-speed electrons and other factors to
    improve S/N ratio.
  • Flexible platform with EI (Electron Ionization), PCI (Positive Chemical Ionization), and NCI (Negative
    Chemical Ionization) techniques.
  • Full complement of acquisition modes including MRM, Scan/MRM, Precursor

Result and Discussion
The mixture of nitrosamines, PAH and phthalates was analysed using the method created. The leachables were quantitatively extracted from sample and evaluated statistically with respect to linearity and precision.

Conclusion
A highly sensitive method was developed for the quantitation of 40 leachables in OINDP products using the Shimadzu GCMS-TQ8040. The MRM method developed for about 40 leachables can be used for screening of leachables in various pharmaceutical products.

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