Near-infrared solid dosage-form analysis

Kaushik D, Madan K, Dureja H. Near-infrared spectroscopy Applications in solid dosage form analysis. Tablets Capsules 2(X)6 4(7) 22-i. 

Two landmark articles published by H. Mark et al. and G. E. Ritchie et al. [30, 31] demonstrate how ICH Q2 principles can be applied when developing a near-infrared method. The first part of the series describes the method validation concepts as described in this section and proposes additional validation protocols. The second part focuses on the implementation of assay and content uniformity methods for solid dosage forms. Authors present at length how each criterion was validated and how they meet ICH and FDA requirements. For instance, repeatability was tested with the predictions of 13 repeats of tablets at three different concentration levels (80,100, and 120% w/w). In addition to the stated guidelines, authors used ASTM E1655-97 [12] to provide statistics analysis that is not directly provided in ICH Q2(R1). 

J.D. Kirsch and J.K. Drennen, Near-infrared spectroscopy applications in the analysis of tablets and solid pharmaceutical dosage forms, Appl Spectrosc. Rev., 30(3), 139-174 (1995). 

Corti, P., Ceramelli, G., Dreassi, E. and Mattii, S. (1999) Near infrared transmittance analysis for the assay of solid pharmaceutical dosage forms Analyst 124, 755-758. 

Near infrared In situ analysis of solid-state conversions identification and quantification of polymorphs in dosage forms... 

Ciurczak, E.W. Torlini, R.P. Analysis of solid and liquid dosage forms using near-infrared reflectance spectroscopy. Spectrosc. 1987, 2 (3), 41 3. 

J. K. Drermen, Near-Infrared Spectroscopy Applications in the Analysis of Tablets and Solid Pharmaceutical Dosage Forms, PhD thesis dissertation. University of Kentucky, 1991. 

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