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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,5μm),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 m L·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0.11~7.93,0.06~4.38,0.11~7.91μg·m L?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。
OBJECTIVE To establish a HPLC method for simultaneous determination of related substances and chlorhexidine acetate in tetracaine hydrochloride mucilage. Methods Kromasil C18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of phosphate buffer acetonitrile. The column temperature was 35 ℃ and the flow rate was 1.0 m L · min -1. Wavelength of 300 nm; chlorhexidine acetate detection wavelength of 258 nm. The results showed that tetracaine hydrochloride was separated from the degradation products. The linearity of tetracaine hydrochloride, p-aminobenzoic acid and p-aminobenzoic acid were 0.11 ~ 7.93,0.06 ~ 4.38,0.11 ~ 7.91μg · m L -1 r = 0.999 9 ~ 1.000 0). The average recovery of chlorhexidine acetate was 100.2% with a RSD of 1.0% (n = 9). Conclusion This method is simple, specific, sensitive and accurate. It can be used for the determination of related substances and chlorhexidine acetate in tetracaine hydrochloride mortar.