盐酸奥洛他定含量及有关物质的HPLC法测定

Determination of Olopatadine Hydrochloride and Its Related Substances by HPLC

建立了高效液相色谱法测定盐酸奥洛他定及其有关物质。使用Zorbax Extend-C18色谱柱,流动相为0.1%三氟乙酸溶液∶乙腈（60∶40）,检测波长224 nm。盐酸奥洛他定与有关物质的分离完全。线性范围为0.005~0.8 mg/ml,平均回收率为100.1%,RSD为0.19%。

An HPLC method was established for the determination of olopatadine hydrochloride and its related substances. A Zorbax Extend-C18 column was used with the mobile phase of 0.1% trifluoroacetic acid solution ： acetonitrile （60 ： 40） at the detection wavelength of 224 rim. Olopatadine hydrochloride and its related substances were separated successfully. It was linear for olopatadine hydrochloride in the concentration range of 0.005--0.8 mg/ml. The average recovery was 100.1%, with RSD of 0.19 %.