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  • Title: Chiral purity assay for Flindokalner using tandem mass spectrometry: method development, validation, and benchmarking.
    Author: Young BL, Cooks RG, Madden MC, Bair M, Jia J, Aubry AF, Miller SA.
    Journal: J Pharm Biomed Anal; 2007 Apr 11; 43(5):1602-8. PubMed ID: 17298872.
    Abstract:
    The present work demonstrates the application and validation of a mass spectrometry method for quantitative chiral purity determination. The particular compound analyzed is Flindokalner, a Bristol-Myers Squibb drug candidate for post-stroke neuroprotection. Chiral quantification of Flindokalner was achieved using tandem mass spectrometry (MS/MS) and the kinetic method, a gas phase method used for thermochemical and chiral determinations. The MS/MS method was validated and benchmarked against two separate chromatographic techniques, chiral high performance liquid chromatography with ultra-violet detection (LC/UV) and achiral high performance liquid chromatography with circular dichroism detection (LC/CD). The chiral purity determination of Flindokalner using MS/MS proved to be rapid (3 min run time for each sample) and to have accuracy and precision comparable to the chiral LC/UV and achiral LC/CD methods. This method represents an alternative to commonly used chromatographic techniques as a means of chiral purity determination and is particularly useful in rapid screening experiments.
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