Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 98, Issue 3, Pages 1155-1166Publisher
JOHN WILEY & SONS INC
DOI: 10.1002/jps.21482
Keywords
near-infrared (NIR); pharmaceutical tablets; content uniformity; multivariate calibration design; partial least-squares regression (PLS)
Ask authors/readers for more resources
Quantification analysis with near-infrared (NIR) spectroscopy typically requires utilizing chemometric techniques, such as partial least squares (PLS) method, to achieve the desired selectivity. This article points out a major limitation of these statistical-based calibration methods. The limitation is that the techniques suffer from the potential for chance correlation. In this article, the impact of chance correlation oil the robustness of PLS model was illustrated via a pharmaceutical application with NIR to the content uniformity determination of tablets. The procedure involves evaluating the PLS models generated with two sets of calibration tablets incorporated with distinct degree of concentration correlation between the active pharmaceutical ingredient (API) and excipients. The selectivity and robustness of the two models were examined by using a series of data sets associated with placebo tablets and tablets incorporated with variations from excipient content, hardness and particle size. The result clearly revealed that the strong correlation observed in the PLS model created by the correlated design was not solely based on the API information, and there was an intrinsic difference in the variances described by the two calibration models. Diagnostic tools that enable the characterization of the chemical selectivity of the calibration model were also proposed for pharmaceutical quantitative analysis. (C) 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1155-1166, 2009
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available