Chen C S, Brown C W
Department of Chemistry, University of Rhode Island, Kingston 02881.
Pharm Res. 1994 Jul;11(7):979-83. doi: 10.1023/a:1018975002025.
A traditional dissolution pumping system was recently replaced with a fiber optic interface between the spectrometer and the samples. However, the system was limited to a single sample vessel. In this study, a dissolution testing system with six vessels connected to a diode array spectrometer via six optical fibers was investigated. A bifurcated fiber optic bundle was used to transfer the light from the source to the dissolution vessels and was networked so that spectra of each sample can be measured periodically. A full spectrum calibration method based on Principal Component Regression (PCR) was used to determine the concentrations of active ingredients and to account for interferences due to excipients in tablet formulations. Results on this new fiber optic interface system are compared with those obtained previously with the traditional pumping system. Standard errors of prediction are between 1.5 and 3.2% using cross-validation and between 1.1 and 1.7% for the direct validation of two active ingredients in two different drug formulations.
最近,传统的溶出度泵送系统被光谱仪与样品之间的光纤接口所取代。然而,该系统仅限于单个样品容器。在本研究中,对一种具有六个容器的溶出度测试系统进行了研究,该系统通过六根光纤连接到二极管阵列光谱仪。采用分叉光纤束将光源发出的光传输到溶出度容器,并通过网络连接,以便能定期测量每个样品的光谱。基于主成分回归(PCR)的全光谱校准方法用于测定活性成分的浓度,并解释片剂配方中辅料产生的干扰。将这种新型光纤接口系统的结果与之前使用传统泵送系统获得的结果进行了比较。使用交叉验证时,两种不同药物制剂中两种活性成分的预测标准误差在1.5%至3.2%之间,直接验证时在1.1%至1.7%之间。