| abstract |
The invention discloses a detection method for hydroxychloroquine sulfate related substances. The method includes the following steps, and the separation and detection are carried out by reversed liquid chromatography; wherein, the chromatographic conditions are: the mobile phase is a mixed solvent composed of a water-soluble organic solvent and a buffer solution; wherein, the buffer solution is acetic acid Ammonium solution or ammonium formate solution; the pH value of the buffer solution is 9.0-10.5. The detection method of the invention can simultaneously detect 7 impurities included in the quality standard of hydroxychloroquine sulfate raw materials in European Pharmacopoeia version 9.8 in the raw materials and preparations of hydroxychloroquine sulfate, and has the advantages of good separation effect, high sensitivity, no blank interference, low detection cost, and high analytical performance. The advantages of fast speed and so on. |