复方氯丙那林质量检控的近红外光谱快速分析

Fast analysis in quality control of compound clorprenaline by near infrared spectroscopy

基于近红外光纤漫反射技术,利用偏最小二乘法分别建立了复方氯丙那林胶囊的三种药效成分盐酸氯丙那林、盐酸溴己新和盐酸去氯羟嗪的快速同时测定方法。所建立的盐酸氯丙那林、盐酸溴己新和盐酸去氯羟嗪的定量分析多元校正模型的相关系数分别为99.7%、99.4%和99.0%,校正集的均方根残差分别为0.028、0.145和0.250,预测均方根误差分别为0.055、0.120和0.210。由于该方法是在不经任何预处理的情况下的光纤快速同时分析,因此可用于复方氯丙那林的过程质量控制。

Based on the near infrared fiber diffuse reflectance spectroscopy, the analytical methods of the fast and simultaneous determinations for clorprenaline hydroehloride, hromhexine hydrochloride and decloxizine hydrochloride contained in the compound clorprenaline have been established by the partial least squares method. The multivariate calibration models for elorprenaline hydrochloride, bromhexine hydroehloride and decloxizine hydroehloride have the good correlations with the correlation coefficients of 99.7% ,99.4% and 99.0% ,and the root mean square errors of 0.028,0. 145 and 0.250 for the calibration sample sets, and the strong prediction abilities with the root mean square errors of 0. 055,0. 120 and 0. 210 for the prediction sample sets, respectively. Because of the fast and simultaneous fiber analyses with no pre-treating,the established method could be used in the process quality control of compound elorprenaline.