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

Authors

  • Márcia Lombardo Instituto Adolfo Lutz Avenida Doutor Arnaldo, 355 01246-900 Pacaembu São Paulo-SP
  • Jaqueline Kalleian Eserian Instituto Adolfo Lutz Avenida Doutor Arnaldo, 355 01246-900 Pacaembu São Paulo-SP

DOI:

https://doi.org/10.14450/2318-9312.v27.e3.a2015.pp191-194

Keywords:

Analysis of Products, Fentanyl, Chromatography, Liquid, Dosage

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.

Author Biographies

Márcia Lombardo, Instituto Adolfo Lutz Avenida Doutor Arnaldo, 355 01246-900 Pacaembu São Paulo-SP

Mestre em Fármaco e Medicamentos pela Faculdade de Ciências Farmacêuticas da USP. Pesquisador científico do Centro de Medicamentos, Cosméticos e Saneantes do Instituto Adolfo Lutz.

Jaqueline Kalleian Eserian, Instituto Adolfo Lutz Avenida Doutor Arnaldo, 355 01246-900 Pacaembu São Paulo-SP

Mestre em Ciências pela Universidade Federal de São Paulo, Departamento de Psicobiologia. Pesquisador científico do Centro de Medicamentos, Cosméticos e Saneantes do Instituto Adolfo Lutz.

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Published

2015-09-30

How to Cite

Lombardo, M., & Eserian, J. K. (2015). INVESTIGATION OF A QUALITY DEVIATION OCCURRENCE ON A FENTANYL CITRATE SOLUTION FOR INJECTION. Infarma - Pharmaceutical Sciences, 27(3), 191–194. https://doi.org/10.14450/2318-9312.v27.e3.a2015.pp191-194

Issue

Vol. 27 No. 3 (2015)

Section

Technical Note

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