UV/VISIBLE SPECTRAL DISSOLUTION MONITORING BY IN-SITU FIBEROPTIC PROBES

A seven-channel fiber-optic UV/visible spectrograph has been developed for in situ dissolution testing of pharmaceutical products. The system employs a spectrograph and a two-dimensional charge-coupled device for detection. This arrangement permits simultaneous monitoring of six dissolution vessels and a seventh reference vessel, Wavelength calibration algorithms were developed to ensure that spectra recorded on each of the seven probes are mutually compatible. Standard reference materials and placebo ingredients were used to create multicomponent calibration models. Multivariate calibration techniques were developed in an effort to produce rugged analytical methods. Four products with single active ingredients were studied. We also conducted a series of studies to determine the reproducibility, both day-to-day and probe-to probe, and linearity and lack of interference from excipients for the assays developed using the new instrument It was determined that in situ dissolution testing is feasible for the formulations studied. The application of this technology is attractive because it saves time and labor and reduces the need for analytical solvents.