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Transmission Raman spectroscopy is a potent new tool for content uniformity testing in pharmaceutical manufacturing enabling rapid bulk sampling of a material by non-destructive means. In this proof-of-concept study, we present, for the first time, comprehensive quantification of all the constituents in a set of tablets consisting of 5 components (3 APIs and 2 excipients) by this method. The nominal concentration of individual components ranged from 1 to 85% (w/w). Two multivariate partial least-squares approaches have been used to calibrate concentration models consisting of 40 handmade tablets covering 20 sample points. These models successfully predicted all the components in a set of 10 validation tablets covering 5 different sample points. A single model for all components (PLS2) and 5 individual models each optimised for one component (PLS1) performed similarity and have been used to demonstrate that specificity of prediction has been achieved through using a multifactor orthogonal DoE for sample preparation. The ability to determine multiple analyte concentrations in one single measurement further establishes this procedure and its benefits for assay and content uniformity testing.

Original publication

DOI

10.1016/j.jpba.2015.07.019

Type

Journal

Journal of pharmaceutical and biomedical analysis

Publication Date

11/2015

Volume

115

Pages

277 - 282

Addresses

Cobalt Light Systems Ltd, 174 Brook Drive, Milton Park, Abingdon, Oxfordshire, OX14 4SD, UK.

Keywords

Phenylephrine, Acetaminophen, Caffeine, Tablets, Excipients, Calibration, Spectrum Analysis, Raman, Multivariate Analysis, Least-Squares Analysis, Reproducibility of Results, Models, Theoretical