A DRUG DISSOLUTION MONITOR EMPLOYING MULTIPLE FIBER OPTIC PROBES AND A UV/VISIBLE DIODE-ARRAY SPECTROPHOTOMETER

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.