METHOD FOR DETERMINING THE CONTENT AND ITS GIDROKSIMETILHINOKSILINDIOKSIDA impurities by HPLC

摘要

1. A method for determining a dosage amount of active substance gidroksimetilhinoksilindioksida component - gidroksimetilhinoksilindioksida (GMHD) and impurities comprising preparing a solution of the test substance; Preparation of standard solutions GMHD and impurities; chromatography solutions prepared by HPLC separation with C18 column size 50 × 3,0 mm filled with a carrier grain size 3.0 .mu.m, or of 150 × 4,6 mm filled with a carrier grain size 5.0 .mu.m using as mobile phase mixture of water and acetonitrile in a ratio of from 90:10 to 95: 5 or a mixture of 0.3% formic acid and acetonitrile in a ratio of from 90:10 to 95: 5 acetonitrile in linear gradient mode on a chromatograph using a UV detector; GHMD identification and impurities obtained on the chromatograms of retention times; calculation GHMD content and its impurities in a drug substance calculated on the basis GHMD formul.2. The method of claim 1, wherein acetonitrile is acetonitrile to hromatografii.3. The method of claim 1, wherein the carrier is a reverse-phase nositel.4. The method of claim 1, wherein determining the content GHMD and impurities carried in the drug.