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| Application of Raman spectroscopy on the rapid screening of paclitaxel liposome preparation |
| ZHAO Yu YIN Lihui HU Changqin |
| Institute for Chemical Drug Control, National Institutes of Food and Drug Control，Beijing 100050, China |
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Abstract Objective To realize the rapid screening on site, Raman spectroscopy was applied to establish an identification model of paclitaxel liposome preparation. Methods Raman spectra of the whole paclitaxel liposome product with package were first collected, and principal component analysis（PCA） algorithm was then used to extract paclitaxelliposome signals from the identified signals. Classic least squares(CLS) algorithm was used to established the identification model. The threshold was determined by the positive validation and negative challenge tests, and identification results would be get by compare the the correlation coefficients with the threshold. External standard method was utilized to realize the model transfer on three different kinds of Raman spectrometer. Results The correlation coefficient between the extracted spectrum and directly-measured spectrum was 0.9744. The paclitaxelliposome identification model was built with a threshold of 0.85, and results of both positive validation and negative challenge tests were all passed. Model transfer results also indicated that with the use of transfer spectra and peak search, the method established could be used on portable Raman, microscope imaging Raman and FT-Raman spectroscopes. Conclusion The Raman method established in this study could realize expensive anticarcinogen both on-site non-invasively and laboratory use, which can provide a scientific and efficient means for regulation and crackdown on counterfeit expensive medicine.
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