HPLC同时测定盐酸丁卡因胶浆中的有关物质和醋酸氯己定的含量

Simultaneous Determination of Related Substances and Chlorhexidine Acetate in Tetracaine Hydrochloride Jelly by HPLC

关键词:  盐酸丁卡因  醋酸氯己定  高效液相色谱法  有关物质  双波长

Key words:  tetracaine hydrochloride  chlorhexidine acetate  HPLC  related substances  dual wavelength

摘要:

目的 建立高效液相色谱法同时测定盐酸丁卡因胶浆中的有关物质和醋酸氯己定含量。方法 采用Kromasil C₁₈色谱柱(150 mm×4.6 mm，5 μm)，流动相为磷酸盐缓冲液-乙腈进行，梯度洗脱，柱温为35 ℃，流速为1.0 mL·min^-1，有关物质检测波长为300 nm；醋酸氯己定检测波长为258 nm。结果 盐酸丁卡因与降解产物分离良好，盐酸丁卡因、对氨基苯甲酸、对丁氨基苯甲酸分别在0.11~7.93，0.06~4.38，0.11~7.91 μg·mL^-1内线性关系良好(r=0.999 9~1.000 0)。醋酸氯己定的平均回收率为100.2%，RSD为1.0%(n=9)。结论 本法简便、专属、灵敏、准确，可用于盐酸丁卡因胶浆中的有关物质和醋酸氯己定含量测定。

Abstract:

OBJECTIVE To establish an HPLC method to determine the content of related substances and chlorhexidine acetate in tetracaine hydrochloride jelly. METHODS Kromasil C₁₈ column(150 mm×4.6 mm, 5 μm) was used. The mobile phase was phosphate buffer-acetonitrile with gradient elution. The column temperature was 35 ℃. The flow rate was 1.0 mL·min^-1. Related substances and chlorhexidine acetate were detected at 300 nm and 258 nm, respectively. RESULTS Tetracaine hydrochloride was completely separated from impurities. The calibration curves of tetracaine, aminobenzoic acid and butyl of aminobenzoic acid were linear in the range of 0.11-7.93, 0.06-4.38, 0.11-7.91 μg·mL^-1(r=0.999 9-1.000 0), respectively. The average recovery of chlorhexidine acetate was 100.2%, RSD=1.0%(n=9). CONCLUSION This method is simple, specific, sensitive, accurate and can be applied to control the related substances and chlorhexidine acetate in tetracaine hydrochloride jelly.