近红外漫反射光谱法快速检测苯磺酸氨氯地平片辅料含量（英文）

Near Infrared Diffuse Reflectance Spectroscopy for Rapid Detection of the Excipients′Contents in Amlodipine Besylate Tablets

将近红外光谱技术和化学计量学相结合快速检测苯磺酸氨氯地平片辅料含量.通过随机青蛙法、变量投影重要性和竞争自适应重加权采样筛选特征波长变量点,采用9种光谱预处理方法对原始光谱进行处理后,分别建立了偏最小二乘法模型和支持向量回归分析模型,并将这两种模型进行了比较.应用优选模型对样品进行了测试,结果表明:对于所涉及的样本,在最优特征波长变量选择上,随机青蛙法效果较好;在模型预测结果上,与支持向量回归分析模型相比,5个指标的偏最小二乘法定量模型的决定系数,预测均方根误差评价参数效果较好,相对分析误差值均大于3.0.样品测试值与实测值标准误差均小于1.30,配对t检验表明,在a=0.05显著性水平上,两者无显著性差异.因此,可采用近红外漫反射光谱法用于苯磺酸氨氯地平片辅料含量的快速检测,该方法重复性、中间精密度、线性、精确性良好,且可为其他药用辅料含量快速检测提供借鉴.

The excipients contents in the Amlodipine Besylate Tablet were rapidly detected combing of the near infrared spectroscopy and Chemometrics.Characteristic wavelength variation points were screened by methods of Random Frog, Variable Importance Projection and Competition Self-Adaptive Reweighted Sampling.After processing the original spectrum by 9 kinds of spectrum pre-processing methods, the Partial Least Squares （PLS） model and Support Vector Regression analysis （SVR） model were established respectively and compared to each other.And then the optimized model was applied to test the samples.The results show that the effect of Random Frog is better for the selection of optimal characteristic wavelength variables in the samples involved;For the model predictions, the effect of PLS quantitative model is better for the evaluation parameters in the determination coefficient and RMSEP of the five indexes, when compared with that of the SVR model, and the Relative Percent Difference （RPD） values are all more than 3.0.The standard error of the tested values and measured values for samples are both less than 1.30;Paired t-test shows that there is no significant difference at the significance level of a=0.05.So near infrared diffuse reflectance spectroscopy can be used to rapidly detect the excipients′ contents in the Amlodipine Besylate Tablets, with a good repeatability, an intermediate precision, a linearity, accuracy, can provide a good reference for the rapid detection of other pharmaceutical excipients′contents.