VALIDATION OF HPLC-PROCEDURES FOR ANALYSIS OF AN EXPERIMENTAL DRUG "REMELTOP"
Validation HPLC-methods of qualitative and quantitative analysis of methyluracile and metronidazole in the structure of the experimental drug, «Remeltop» was performed. In liquid chromatograph LC-20 of the company «SHIMADZU» (Japan) with UV detector with further computer processing of the results of research using the program «LCsolution version 1.4» studies were conducted. Stationary phase - chromatography column 4,6 x 150 mm PerfectChrom C-18, a particle size of 5 nm («MZ-Analysentechnik», Germany). The mobile phase: trifluoroacetic acid a solution of 0.1%, B: acetonitrile 100%. Gradient elution concentration changes of eluent B from 10% to 50%, duration of the analysis 8 min. The technique for quality assessment Remeltop (a powder for oral suspension) can be used, as experimentally defined settings linearity (R2=0,9991, y=233600×x-19,458; R2=0,9993, y=7490576×x+0,246), application range (50 to 150%), precision in terms of the frequency of occurrence (RSD=0,50%; 1,04%; 1,75%), correctness ( =95,52±0,56%, 99,96±0,16%) for methyluracile and metronidazole respectively, which do not exceed the recommended values.