Abstract
A method for determining buprenorphine and naloxone in human plasma using liquid chromatography and high-resolution time-of-flight mass spectrometry (LC-MS Q-TOF) was developed. The sample preparation technique included liquid extraction with salting out of the analytes in Toxi-Tubes Aintended for the determination of neutral and basic compounds. Quantitative analysis was carried out by the internal standard method. Naltrexone, which was structurally similar to the analytes, was used as the internal standard. The proposed method was developed for clinical trials of the new drug bupraxone, a sublingual dosage form containing buprenorphine and naloxone at doses of 0.2 mg each. The bioavailability of the drug components upon sublingual administration was studied. The buprenorphine concentrations in human plasma after administration at a dose of 0.4 mg via two routes (intravenous and sublingual) were compared.
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