Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5137754 | Journal of Pharmaceutical and Biomedical Analysis | 2017 | 22 Pages |
Abstract
Herein we present an alternative system that may be used for photostability testing mimicking both situations. It combines a tailored photoreactor with an exchangeable pen light source and a modified HPLC system with online-SPE. Identification of photoproducts may be performed using mass spectrometry. The potential of accurate mass spectrometry as a tool for identification of photoproducts was demonstrated as well. A comparison of the online photoreactor system and the traditional photochamber irradiation was performed using ketoprofen for proof of concept. In both designs acetylbenzophenone and ethylbenzophenone were detected as main photoproducts. The new device allows for fast and easy photostability studies that may help to reduce time consuming in vitro experiments and animal trials. Using state of the art instruments kinetic studies could also easily be performed with qualitative and quantitative perspectives combined into one experimental design with only very low amounts of API needed. This may be useful in early drug development, where only small amounts of API are available. Scale-up may also be easily realized for the generation of reference material for quantification and quality control (QC) processes as well as for toxicity testing.
Keywords
N-methyl-N-trimethylsilyl-trifluoroacetamideqTOFMSDDADUHPLCESI+ppmSPETMCsAPIUV-AtBMEFDAMSTFAESInuclear magnetic resonancem/zMass selective detectorUS Food and Drug AdministrationSolid phase extractiondiode array detectionNMRRetention timequadrupole time-of-flightonline systemProduct identificationinternational council for harmonisation of technical requirements for pharmaceuticals for human useMass spectrometryPhotostabilityRadio frequencyparts per millionICHActive Pharmaceutical Ingredientketoprofenhigh performance liquid chromatographyUltra High Performance Liquid ChromatographyHPLCGas chromatographyChlorotrimethylsilanequality controlMolecular ionelectrospray ionizationPositive electrospray ionizationelectron ionization
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Jaber Assaf, Diego Zulkiewicz Gomes, Bernhard Wuest, Maria Kristina Parr,