Assessment of light stability of drugs in blood and plasma.
OBJECTIVE
A procedure was developed for the assessment of photochemical stability of drugs in blood and plasma under standardized conditions. The procedure avoids a variable outcome of photochemical stability experiments and tests relevant worst case conditions so that unnecessary light protection is avoided. Results/methodology: Blood and plasma were spiked with a mixture of drugs and incubated in a Suntest CPS(+), in the laboratory on the bench and near the window on a sunny summer day. The results were compared.


CONCLUSIONS
No protection from light, limited protection from light and full protection from light are advised for drugs that are stable in plasma in the Suntest CPS(+) at 250 W/m(2) for at least 30 min, for 5-30 min and for <5 min, respectively.
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Ronald
R
de Vries
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Luc
L
Diels
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Lieve
L
Dillen
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Luc
L
Sips
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Dirk
D
Van Roosbroek
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Tom
T
Verhaeghe
Janssen Research & Development, Turnhoutseweg 30, 2340 Beerse, Belgium.
Philip
P
Timmerman
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006801:Humans; D008027:Light; D004364:Pharmaceutical Preparations / Q000097:blood* / Q000528:radiation effects*; D010782:Photolysis / Q000528:radiation effects; D053719:Tandem Mass Spectrometry; D014466:Ultraviolet Rays
D004364:Pharmaceutical Preparations
LC–MS/MS; bioanalysis; blood; method validation; photochemical degradation; plasma