Abstract

Many pharmaceuticals include highly potent active pharmaceutical ingredients (API), which only require a small dosage to obtain the desired therapeutic effect. This leads to a challenge for quantification of the API using process analytical technology, since the standard nondestructive measurement technique, near-infrared spectroscopy, is not able to quantify below 1% (weight/weight (w/w)) API content. In formulations with more than one API, this challenge is further increased. The purpose of this study is to scrutinize the potential of fluorescence spectroscopy for the simultaneous quantification of two APIs: flupentixol (FLU) in low dosage (0.208-0.625% w/w free base) and melitracen (MEL) (4.17-12.5% w/w free base) in a tablet formulation. Despite internal quenching between the ingredients and the two APIs, this paper demonstrates that it is possible to establish calibrations using partial least squares (PLS) regression on unfolded fluorescence landscapes with a root mean square error of prediction and relative error of 0.038% (w/w) and 9.1%, for FLU and 0.344% (w/w) and 4.1% for MEL, respectively.

Comprehensive study of solid pharmaceutical tablets in visible, near infrared (NIR), and longwave infrared (LWIR) spectral regions using a rapid simultaneous ultraviolet/visible/NIR (UVN) + LWIR laser-induced breakdown spectroscopy linear arrays detection system and a fast acousto-optic tunable filter NIR spectrometer

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Density-dependent determination of scattering properties of pharmaceutical tablets using coherent backscattering spectroscopy

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Broadband photon time-of-flight spectroscopy of pharmaceuticals and highly scattering plastics in the VIS and close NIR spectral ranges

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Authentication of gold nanoparticle encoded pharmaceutical tablets using polarimetric signatures

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Identification and quantification of vegetable oil adulteration with waste frying oil by laser-induced fluorescence spectroscopy

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OSA Continuum 2(4) 1148-1154 (2019)