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  • Applicability of UV laser-induced solid-state fluorescence spectroscopy for characterization of solid dosage forms.

Applicability of UV laser-induced solid-state fluorescence spectroscopy for characterization of solid dosage forms.

Analytical and bioanalytical chemistry (2014-08-12)
Eva Woltmann, Hans Meyer, Diana Weigel, Heinz Pritzke, Tjorben N Posch, Pablo A Kler, Klaus Schürmann, Jörg Roscher, Carolin Huhn
ABSTRACT

High production output of solid pharmaceutical formulations requires fast methods to ensure their quality. Likewise, fast analytical procedures are required in forensic sciences, for example at customs, to substantiate an initial suspicion. We here present the design and the optimization of an instrumental setup for rapid and non-invasive characterization of tablets by laser-induced fluorescence spectroscopy (with a UV-laser (λ ex = 266 nm) as excitation source) in reflection geometry. The setup was first validated with regard to repeatability, bleaching phenomena, and sensitivity. The effect on the spectra by the physical and chemical properties of the samples, e.g. their hardness, homogeneity, chemical composition, and granule grain size of the uncompressed material, using a series of tablets, manufactured in accordance with design of experiments, was investigated. Investigation of tablets with regard to homogeneity, especially, is extremely important in pharmaceutical production processes. We demonstrate that multiplicative scatter correction is an appropriate tool for data preprocessing of fluorescence spectra. Tablets with different physical and chemical characteristics can be discriminated well from their fluorescence spectra by subjecting the results to principal component analysis.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Quinine hemisulfate salt monohydrate, BioReagent, suitable for fluorescence, 99.0-101.0%
Sigma-Aldrich
Quinine hemisulfate salt monohydrate, tested according to Ph. Eur.
Sigma-Aldrich
Quinine hemisulfate salt monohydrate, synthetic, ≥90% (HPLC)
Sigma-Aldrich
Magnesium stearate, puriss., meets analytical specification of Ph. Eur., BP, ≥90% stearic and palmitic acid basis, ≥40% stearic acid basis (GC), 4.0-5.0% Mg basis (calc on dry sub.)
Sigma-Aldrich
Magnesium stearate, technical grade
Quinine sulfate, meets USP testing specifications, monograph mol wt. 782.94 ((C20H24N2O2)2 . H2SO4 . 2H2O)