厄多司坦原料药中有关物质的测定方法

HPLC determination of the related substances in erdosteine

摘要:
建立厄多司坦原料药中有关物质的反相高效液相色谱测定方法。以ODS-SunFire (250 mm ´ 4.6 mm ID, 5 μm) 为分析柱; 甲醇-乙腈-0.01 mol·L⁻¹枸橼酸溶液 (pH 2.5) (20∶4∶76) 为流动相, 流速为1 mL·min⁻¹; 检测波长254 nm。采用加或不加校正因子的主成分自身对照法控制原料药中有关物质。在选定的色谱条件下, 厄多司坦与有关杂质分离良好。以主成分计, 检测限为0.2 μg·mL⁻¹ (S/N = 3)。该方法能够有效地控制厄多司坦原料药中的有关物质。

Abstract:
An HPLC method was established for the determination of the related substance in erdosteine. Waters ODS-SunFire (250 mm ´ 4.6 mm ID, 5 μm) column was used, the mobile phase was composed of methanol-acetonitrile-0.01 mol·L⁻¹ citric acid (20∶4∶76, the pH value was adjusted by triethylamine to 2.5). The flow rate was 1 mL·min⁻¹. The detection wavelength was 254 nm. The related substances in the sample of erdosteine taken were calculated by self control with or without the response factor of impurity relative to that of erdosteine. Under the chromatographic condition developed, the impurities in erdosteine were isolated well. The detection limit was 0.2 μg·mL⁻¹ (Signal/Noise = 3) by principal component calculated. The method can be adopted to control the related substances in erdosteine.