Identification of pharmaceutical tablets by Raman spectroscopy and chemometrics
Identification of pharmaceutical tablets by Raman spectroscopy and chemometrics
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DOI：
10.1016/j.talanta.2010.01.046
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发表时间：
2010-05-15
期刊：
影响因子：
6.1
通讯作者：
Margot, Pierre
中科院分区：
文献类型：
--
作者：
Roggo, Yves;Degardin, Klara;Margot, Pierre
拉曼光谱已成为一种有吸引力的分析药物固体剂型的工具。在本研究中，它被用来确保片剂的身份。该方法的两个主要应用是最终产品的放行质量控制和假冒产品的检测。光谱库中包含了25个产品族的片剂，并采用了非线性分类方法，即支持向量机（svm）。级联开发了两种校准：第一个确定产品族，第二个指定配方。产品族包括具有相同活性药物成分（API）但含量不同的不同配方。一旦使用SVM模型对片剂进行分类，就可以应用API峰检测和相关性，以便有一个特定的识别方法，并允许将来区分假冒产品和正品。该校准策略能够在没有样品先验信息的情况下无误差地识别25个产品族。因此，拉曼光谱与化学计量学相结合是一种快速准确的药物片剂鉴定工具。(C) 2010 Elsevier B.V.版权所有
Raman spectroscopy has become an attractive tool for the analysis of pharmaceutical solid dosage forms. In the present study it is used to ensure the identity of tablets. The two main applications of this method are release of final products in quality control and detection of counterfeits. Twenty-five product families of tablets have been included in the spectral library and a non-linear classification method, the Support Vector Machines (SVMs), has been employed. Two calibrations have been developed in cascade: the first one identifies the product family while the second one specifies the formulation. A product family comprises different formulations that have the same active pharmaceutical ingredient (API) but in a different amount. Once the tablets have been classified by the SVM model, API peaks detection and correlation are applied in order to have a specific method for the identification and allow in the future to discriminate counterfeits from genuine products. This calibration strategy enables the identification of 25 product families without error and in the absence of prior information about the sample. Raman spectroscopy coupled with chemometrics is therefore a fast and accurate tool for the identification of pharmaceutical tablets. (C) 2010 Elsevier B.V. All rights reserved.