Fluorescence spectroscopy in process analytical technology (PAT): simultaneous quantification of two active pharmaceutical ingredients in a tablet formulation

Applied Spectroscopy
Solveig WarneckeSøren Balling Engelsen

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.

References

May 18, 2000·Journal of Pharmaceutical and Biomedical Analysis·I A ShehataF Belal
Dec 4, 2003·Journal of Pharmaceutical Sciences·Chee-Kong Lai, Charles C Cooney
Jun 15, 2006·Chemical Reviews·Jakob ChristensenSøren Balling Engelsen
Sep 21, 2007·Journal of Pharmaceutical and Biomedical Analysis·Jinjing CheYuanguo Cheng
Mar 12, 2008·Alimentary Pharmacology & Therapeutics·J G HashashA I Sharara
Feb 17, 2010·International Journal of Pharmaceutics·Reuben DomikeCharles L Cooney

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Citations

Dec 12, 2019·Analytical Chemistry·Krishnakumar ChullipalliyalilMichael A P McAuliffe

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Methods Mentioned

BETA
fluorescence spectroscopy
Fluorescence
PCA

Software Mentioned

iPLS
PARAFAC
Matlab
Varian Cary Eclipse

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