Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 3, March 2008, pp. 193-198
A Rapid Simple Approach to Screening Pharmaceutical
Products Using Ultra-Performance LC Coupled to Time-of-Flight
Mass Spectrometry and Pattern Recognition
Robert S. Plumb[1], Michael D. Jones[2], Paul
D. Rainville[2], and Jeremy K. Nicholson[1]
[1]Imperial College, Faculty of Medicine, Sir Alexander Fleming
Building, South Kensington, London, UK, SW7 and
[2]Waters Corporation,
34 Maple Street, Milford, MA, 01757
The comparison of batches of pharmaceutical product
or raw active pharmaceutical ingredients (API) for product release
can be time consuming and tedious process. It often requires
long analysis times and potentially several liquid chromatography–tandem
mass spectrometry (LC–MS–MS) analytical runs to determine
the identity of the impurities and their relationship to the
active pharmaceutical ingredient. The combination of a high resolution
(sub 2 µm porous particle) LC coupled to exact mass MS,
principal components analysis (PCA) allowed for the rapid classification
of batches of Simvastatin tablets according to their impurity
profile. Evaluating the ultra-performance LC–MS exact mass
data with PCA allowed for the impurities of Simvastatin to be
easily detected and identified. This approach to impurity batch
analysis should be applicable to many other forms of batch analysis,
fermentation broths, food production, and API manufacturing.
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