DEVELOPMENT AND VALIDATION OF THE METHOD OF QUANTITATIVE DETERMINATION OF FLUORINE-CONTAINING DRUGS BY THE METHOD OF HIGHLY EFFECTIVE LIQUID CHROMATOGRAPHY

Objective. To develop and validate methods for the quantitative determination of fluorine-containing drugs in tablets by high performance liquid chro-matography. Material and methods. In the work we used: pharmaceutical substance and tablets of linezolid, efavirenza and ofloxacin, which meet the requirements of regulatory documents. To develop methods for detecting and quantifying linezolid, efavirenz, and ofloxacin in tablets, a reverse-phase version of high-performance liquid chromatography in gradient elution was used, the conditions of which were selected experimentally. Optimal chromatographic conditions: column size - 75 × 2 mm, polymer sorbent - ProntoSil 120-5C AQ, mobile phase - Eluent A: 0.2 M LiClO4 - 0.005 M HClO4 (pH 2,8), Eluent B: Acetonitrile, gradient: 3700 μl from 5% to 70% eluent B, flow rate 100 μl / min, column temperature 40 ° C, sample volume 2 μl, wavelength 210 nm. Results. The conditions found were used to develop methods for the quantitative content of these substances in tablets. The retention times of oflox-acin were 15.39 minutes, linezolid 16.16 minutes and efavirenza 34.49 minutes. The relative error of the quantitative determination by the developed methods does not exceed 1.22% for ofloxacin, 1.08% for linezolid and 1.39% for efavirenz. Findings. During the study, unified methods were devel-oped for the quantitative determination of fluorine-containing heterocyclic drugs - linezolid, efavirenz, and ofloxacin in tablets by high-performance liquid chromatography. A validation assessment of the developed methods was carried out. Thus, the developed methods make it possible to obtain suffi-ciently reliable and reproducible results for the intended field of application and can be recommended for pharmaceutical, chemical-toxicological, and forensic chemical analysis.