论文部分内容阅读
建立反相高效液相色谱法测定氨苯砜的有关物质。采用Waters SunFire C18(250mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.01mol/L磷酸二氢钠溶液(20∶80,V/V)到(80∶20,V/V)进行梯度洗脱,测定波长为296nm,柱温25℃,流速为1.0mL/min。氨苯砜与其有关物质能完全分离,样品中最多可检测出6个有关物质,单个杂质含量小于0.1%,总杂质含量小于1%。该方法准确、可靠,能有效进行氨苯砜有关物质的限量检查。
To establish a reversed-phase high performance liquid chromatographic determination of dapsone related substances. The gradient was performed on a Waters SunFire C18 (250 mm × 4.6 mm, 5 μm) column with a mobile phase of acetonitrile-0.01 mol / L sodium dihydrogen phosphate solution (20:80, V / V) to The elution was carried out at a wavelength of 296 nm with a column temperature of 25 ° C and a flow rate of 1.0 mL / min. Dapsone and its related substances can be completely separated, the sample can detect up to 6 related substances, a single impurity content of less than 0.1%, the total impurity content of less than 1%. The method is accurate and reliable, and can effectively limit the amount of dapsone related substances.