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药品的安全、有效、质量可控是上市药品应具有的最基本属性。如何运用现代药物分析技术对上市的药品质量实现精准控制是药品监管人员面临的重大挑战。高效液相色谱法(HPLC)分析作为现代药物分析中的最常用方法,已经广泛应用于各类药品的精准质量控制。然而对化学结构中缺少特征紫外吸收基团的药物如氨基糖苷类抗生素等的检测,一直是HPLC分析的难点。HPLC-电化学检测(HPLC-ED)采用电化学原理依据物质的电化学性质进行检测,具有高灵敏度、高选择性的特点。近年来,欧美等国药典逐渐采用HPLC-脉冲安培电化学检测器(pulsed
The safe, effective and quality control of medicines is the most basic attribute of listed medicines. How to use modern drug analysis technology to accurately control the quality of listed drugs is a major challenge for drug regulatory personnel. High-performance liquid chromatography (HPLC) analysis, as the most commonly used method in modern pharmaceutical analysis, has been widely used for precise quality control of various drugs. However, the lack of features in the chemical structure of the UV absorption group of drugs such as aminoglycoside antibiotics, such as detection, HPLC analysis has been the difficulty. HPLC-electrochemical detection (HPLC-ED) using electrochemical principles based on the electrochemical properties of substances detected with high sensitivity, high selectivity characteristics. In recent years, Pharmacopoeia of Europe and the United States and other countries gradually adopted HPLC-pulsed amperometric detector (pulsed