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 chromatography. 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 x 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 pl from 5% to 70% eluent B, flow rate 100 pl / min, column temperature 40 ° C, sample volume 2 pl, 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 ofloxacin 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 developed 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 sufficiently reliable and reproducible results for the intended field of application and can be recommended for pharmaceutical, chemical-toxicological, and forensic chemical analysis.

ofloxacin, linezolid, efavirenz, high performance liquid chromatography, quantitation