HPLC法测定水杨酸原料药的有关物质

目的: 建立RP-HPLC法测定水杨酸原料药的有关物质。 方法: 采用Phenomenex Luna C₁₈柱(4.6 mm×150 mm,5 μm),流动相为甲醇-水-冰醋酸(60∶ 40∶ 1),流速1.0 mL·min^-1,检测波长270 nm。 结果: 水杨酸与4-羟基苯甲酸、4-羟基间苯二甲酸和苯酚分离度良好,3种杂质在0.958~19.16 μg·mL^-1、0.4912~9.824 μg·mL^-1、0.214~4.28 μg·mL^-1之间线性关系良好,检测限分别为0.025 μg·mL^-1、0.025 μg·mL^-1、0.04 μg·mL^-1。 结论: 本方法简便、准确,专属性好,灵敏度高,可作为水杨酸原料药有关物质的检查方法。

Objective: To establish an HPLC method for determination of relater substances of salicylic acid. Methods: Phenomenex Luna C ₁₈(4.6 mm×150 mm,5 μm)was adopted with methanol-water-acetic acid(60∶ 40∶ 1) as mobile phase at the flow rate of 1.0 mL·min^-1,detection was set at 270 nm. Results: Good separation of salicylic acid and other substance could be achieved.Three kinds of material and linear relationship was good,The detection limits were 0.025 μg·mL^-1,0.025 μg·mL^-1 and 0.04 μg·mL^-1. Conclusion: This method is simple,sensitive,selective and repetitive,accurate for analysis of related substances of salicylic acid.