Monitoring batch-to-batch reproducibility using direct analysis in real time mass spectrometry and multivariate
Shanshan Zeng1, Teng Chen, Lu Wang
1Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Abstract:
Batch-to-batch variability of traditional Chinese medicine (TCM) has already heavily limited its industrial development. By utilizing direct analysis in real time mass spectrometry (DART-MS) and multivariate statistical analysis, the present study introduced a novel and rapid methodology for TCM manufacturing process monitoring. Danshen alkaline precipitation was employed as an example operating unit to demonstrate the effectiveness of this new technique. A total of 15 batches run under normal operating conditions were used to develop a reference principal component analysis model and then enabled the establishment of multivariate control charts. Hotteling T(2) and DModX charts were applied to examine batch-to-batch reproducibility of 12 test batches. Artificial variations including starting material change and process fault were identified, which was in a good agreement with conventional analysis result. Further understanding of the deviating process behavior was achieved by investigating the contribution plot of abnormal batches. The results showed that DART-MS, in conjunction with multivariate analysis, provided valuable information on model process and gave us a new perspective for TCM manufacturing process monitoring.
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