RESUMO
BACKGROUND: To develop and validate an ultrasensitive bioanalytical assay for quantitation of fluticasone propionate in human plasma, aliquots of 0.6 ml of K(3)EDTA human plasma were treated with zinc sulfate solution and loaded onto a preconditioned SPE plate. The sample solutions were washed, eluted, dried and reconstituted. The extracted sample was injected onto a LC-MS/MS system and separated by a reverse-phase HPLC column with a 5 min gradient program, and detected by MS/MS for fluticasone propionate quantitation. RESULTS: Linearity was from 1 to 200 pg/ml. The intra- and inter-day accuracy and precision of the assay met validation acceptance criteria. Various stabilities were established and interference drug assessment was evaluated. The assay has been used for clinical studies. CONCLUSION: This ultrasensitive method has been successfully validated using LC-MS/MS for determination of fluticasone propionate in human plasma at low pg/ml level.