HPLC-PDA法测定恩诺沙星注射液中非法添加乙酰甲喹、水杨酸

Determination Addition of Maquindox and Salicylic Acid in Enrofloxacin Injection by HPLC

关键词:  乙酰甲喹  水杨酸  非法添加  测定  高效液相色谱法

Key words:  Acetylquine  Salicylic acid  Illegal addition  Determination  High performance liquid chromatography (HPLC)

摘要:

建立了高效液相色谱法测定恩诺沙星注射液中非法添加乙酰甲喹、水杨酸含量的方法。试验采用十八烷基硅烷键合硅胶色谱柱,以0.025moL/L磷酸溶液-乙腈(85:15, v/v)为流动相,流速为1.0 mL/min,二极管阵列检测器进行全扫描和232nm波长测定。结果表明乙酰甲喹在0.5～20μg/mL范围内线性良好,R²=1.000,回收率在98.21%～107.94%之间；水杨酸在1.0～50μg/mL范围内线性良好,R²=1.000,回收率在96.33%～100.84%之间；RSD在0.11%～3.44%之间。本方法准确、可靠、重现性好,可用于恩诺沙星注射液中非法添加乙酰甲喹、水杨酸的定性和定量检测。

Abstract:

A method for content determination of Maquindox and Salicylic Acid in Enrofloxacin Injection by HPLC was developed and validated. Analysis was performed on a C18 column with a mobile phase of phosphorous acid solution–methanol (85:15, v/v) at a flow rate of 1.0 mL/min. The diode array detector was fully scanned and The determination wave length was 232 nm. The results showed that acetoquine was linear in the range of 0.5-20 μg/mL, R2=1.000, the recovery was between 98.21% and 107.94%; salicylic acid was linear in the range of 1.0-50 μg/mL, R2=1.000, recovery The rate is between 96.33% and 100.84%; the RSD is between 0.11% and 3.44%. The method is accurate, reliable and reproducible, and can be used for qualitative and quantitative detection of illegal addition of acetoquine and salicylic acid in enrofloxacin injection.