A new method has been developed utilizing Carona Charged Aerosol (CAD-PLUS) detection, whereby molecules with and without chromophores can be assessed and tracked in both synthetic and animal-derived lung surfactants via charged nebulization of the sample with nitrogen flow, capable of assessing four actives and related impurities in Lucinactant (SURFAXIN®; Discovery Laboratories, Inc., Warrington PA), a precision-engineered synthetic lung surfactant.

Method

Analytics utilizing HPLC-CAD (Charged Aerosol Detection) has been developed to assess product impurity profiles in various pulmonary surfactant formulations, both synthetic and animal-derived.

Results

Employ of HPLC-CAD analysis provides a means for impurity profiling and analytic assessment, with concomitant laboratory efficacy benefits, of a new synthetic pulmonary surfactant (Surfaxin®) versus currently marketed animal-derived surfactants. This analytical platform allows for all lipid-related impurities to be tracked and targeted with respect to their active parent compounds. One method of analysis was able to be developed using CAD detection, whereas prior several methods had to be employed, as some compounds lacked chromophores. Increased specificity and sensitivity was achieved using HPLC-CAD. Mass Spectrometry was conducted to support compound identification and method specificity.

Conclusion

The application of HPLC-CAD analytics allowed for the development of one method capable of monitoring four actives (R2 ≥ 0.99) and six known impurities (R2 ≥ 0.98) within SURFAXIN® drug product. Use of this new method also provides a means of assessing and comparing impurity profiles between synthetic surfactant drug product versus that exhibited by current marketed animal-derived surfactant drug product.