Determination of figures of merit for near-infrared and Raman spectrometry by net analyte signal analysis for a 4-component solid dosage system

AAPS PharmSciTech
Steven M ShortCarl A Anderson

Abstract

Process analytical technology has elevated the role of sensors in pharmaceutical manufacturing. Often the ideal technology must be selected from many suitable candidates based on limited data. Net analyte signal (NAS) theory provides an effective platform for method characterization based on multivariate figures of merit (FOM). The objective of this work was to demonstrate that these tools can be used to characterize the performance of 2 dissimilar analyzers based on different underlying spectroscopic principles for the analysis of pharmaceutical compacts. A fully balanced, 4-constituent mixture design composed of anhydrous theophylline, lactose monohydrate, microcrystalline cellulose, and starch was generated; it consisted of 29 design points. Six 13-mm tablets were produced from each mixture at 5 compaction levels and were analyzed by near-infrared and Raman spectroscopy. Partial least squares regression and NAS analyses were performed for each component, which allowed for the computation of FOM. Based on the calibration error statistics, both instruments were capable of accurately modeling all constituents. The results of this work indicate that these statistical tools are a suitable platform for comparing dissimilar analyze...Continue Reading

References

Jan 31, 2002·Journal of Biomedical Optics·Ralf Marbach
May 1, 2004·Analytical Chemistry·Hans F M BoelensAge K Smilde

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Citations

Jul 16, 2008·Journal of Pharmaceutical Sciences·Steven M ShortCarl A Anderson
Oct 18, 2011·Drug Development and Industrial Pharmacy·Raphaela Regina de Araújo Pereira, Marcos Luciano Bruschi
Nov 7, 2016·Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy·Jagdish TewariPierre Boulas
May 23, 2014·Drug Delivery·Susijit SahooSunit Kumar Sahoo
Mar 10, 2017·Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment·Santosh LohumiByoung-Kwan Cho
Jul 19, 2018·Journal of Pharmaceutical Sciences·Raj MukherjeeBodhisattwa Chaudhuri
Jan 24, 2009·Analytical Chemistry·Zhenqi Shi, Carl A Anderson

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