INVESTIGATION OF A QUALITY DEVIATION OCCURRENCE ON A FENTANYL CITRATE SOLUTION FOR INJECTION

Abstract

Fentanyl is a pain reliever drug for hospital use mainly indicated as an anesthesia adjunct. Due to a complaint made by
a hospital located in São Paulo, related to therapeutic failure of an injectable solution containing fentanyl citrate after
use in anesthesia, samples of the product were collected for analysis by health services. The objective of this study
was to perform physico-chemical tests on the samples, with priority to quantification and drug identification, using a
high performance liquid chromatograph couppled with diode array detector. The two batches analyzed showed positive
identification of fentanyl citrate and 97.30% of the drug content; these results were in accordance to recommended range
by the product manufacturer. Thus, it was possible to exclude deviations in the drug content as the cause for therapeutic
inefficacy, indicating the need for additional investigation and raising further discussion of the case.