摘要
目的：建立高效液相色谱法测定盐酸丁卡因滴眼液中盐酸丁卡因的含量。方法：采用AgilentSB—C18色谱柱（4．6mm×250mm，5μm）；流动相为甲醇-水-三乙胺-冰醋酸（75：25：0．5：0．2）；检测波长310nm；流量1．0mL·min-1；进样量20μ；柱温30℃。结果：盐酸丁卡因在4～16μg·mL-1范围内线性关系良好（r=0．9999），平均回收率为100．0％（RSD=0．71％）。结论：本方法简便、快速、准确，专属性强。为盐酸丁卡因滴眼液中盐酸丁卡因含量测定方法的修订提供了依据。
Objective： The HPLC method was established for tetracaine hydrochloride eye drops. Methods ：The separation was performed on Agilent SB-C18 （4. 6 mm×250 ram,5μm）. The mobile phase was composed of methanol-water-triethylamine-glacial acetic acid（75：25 ：0. 5：0. 2）. The flow rate was 1.0 mL·min-1. The detective wavelength was 310 nm. The chromatography was conducted at 30 ℃. Results： The linear range of tetracaine hydrochloride was 4-16 μg·mL-1 （r =0. 9999 ） . The average recovery was 100. 0% ,and the RSD was 0. 71%. Conclusion：The method is proved to be simple ,quick and accurate and is suitable for the determination of tetracaine hydrochloride. It provids reference for the content determination of tetracaine hydrochloride eye drops.
出处
《中国药品标准》
CAS
2013年第5期356-357,400,共3页
Drug Standards of China
