In-Situ Fiber Optic Dissolution Testing – Multi-Component analysis

Traditionally, analyzing more than one active pharmaceutical ingredient (API) with UV spectrophotometry poses a challenge as both species often absorb over the same spectral region, causing deviations from Beer’s Law. This linear relation between absorbance and the absorbing species is used to calculate concentration values based on the measured absorbance at a specific wavelength. Separation techniques such as HPLC are often reverted to when analyzing mixture samples with more than one API due to the concentration calculation errors caused by the spectral overlap. However, Multicomponent Analysis (MCA) algorithm and complete spectral profiles collected using a fiber optic UV dissolution analyzer overcome these obstacles. This is accomplished using the Classical Least Squares form of Multiple Linear Regression to analyze the two spectrally overlapping components. The algorithm uses a calibration matrix of extinction coefficients derived from the spectra of multiple standard solutions to calculate component concentrations in an unknown mixture.

This study demonstrates the MCA algorithm capability, used in tandem with in-situ fiber optics, to accurately monitor and quantify the dissolution profile of a commercial product containing two APIs, eliminating the need to draw samples for HPLC analysis