Определение бупренорфина и налоксона в плазме крови пациентов методом ВЭЖХ-масс-спектрометрии

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) has been developed. The sample preparation technique includes liquid extraction with salting-out of analytes in Toxi-Tubes A intended for the determination of neutral and basic substances. Quantitative analysis is carried out by the method of internal standard. Naltrexone, a compound structurally close to analytes, has been used as the internal standard. The proposed method has been developed for clinical tests of a new drug bupraxone, which represents a sublingual dosage form containing buprenorphine and naloxone in a dose of 0.2 mg each. Bioavailability of the drug components for sublingual administration has been studied and comparative evaluation of the buprenorphine concentration in human plasma upon administration at a dose of 0.4 mg via two routes (sublingual and intravenous) has been carried out.