高效液相色谱法同时测定口腔溃疡油中盐酸达克罗宁和醋酸氯己定含量  

Simultaneous Determination of Dyclonine Hydrochloride and Chlorhexidine Acetate in Dental Ulcer Oil by HPLC

作　　者：熊英 雷健 邢茂 XIONG Ying;LEI Jian;XING Mao(Department of Pharmacy,The Second Affiliated Hospital,Army Medical University,Chongqing,China 400037)

机构地区：[1]中国人民解放军陆军军医大学第二附属医院药学部,重庆400037

出　　处：《中国药业》2022年第13期67-70,共4页China Pharmaceuticals

基　　金：军队医疗机构制剂标准提高科研专项课题面上项目[14ZJZ06-2]。

摘　　要：目的提高口腔溃疡油的质量标准。方法采用高效液相色谱法同时测定口腔溃疡油中盐酸达克罗宁和醋酸氯己定的含量,色谱柱为Phenomenex Luna C_(8)柱(250 mm×4.6 mm,5μm),流动相为甲醇(A)-0.02 mol/L KH_(2)PO_(4)溶液(B,冰醋酸调pH至2.5),梯度洗脱(0~20 min时45%A,20~21 min时45%A~60%A,21~30 min时60%A,30~31 min时60%A~45%A,31~35 min时45%A),流速为1.0 mL/min,检测波长为259 nm,柱温为30℃,进样量为10μL。结果盐酸达克罗宁和醋酸氯己定的质量浓度分别在39.23~196.17μg/mL和3.87~19.35μg/mL范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于1%(n=6);平均加样回收率分别为101.18%和98.74%,RSD分别为0.79%和0.94%(n=9);耐用性试验的RSD分别为0.95%和1.37%(n=9)。结论该方法专属性强、准确度高、重复性和耐用性良好,可用于提升口腔溃疡油的质量标准。Objective To improve the quality standard of Dental Ulcer Oil.Methods The contents of dyclonine hydrochloride and chlorhexidine acetate in Dental Ulcer Oil were simultaneously determined by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Phenomenex Luna C_(8) column(250 mm×4.6 mm,5μm),the mobile phase was methanol(A)-0.02 mol/L KH_(2)PO_(4) solution(B,adjusted to pH 2.5 with glacial acetic acid),the elution method was gradient elution(45%A at 0-20 min,45%A-60%A at 20-21 min,60%A at 21-30 min,60%A-45%A at 30-31 min and 45%A at 31-35 min),the flow rate was 1.0 mL/min,the detection wavelength was 259 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The linear ranges of dyclonine hydrochloride and chlorhexidine acetate were 39.23-196.17μg/mL and 3.87-19.35μg/mL,respectively.The RSDs of precision,stability and repeatability tests were less than 1%(n=6).The average recoveries of dyclonine hydrochloride and chlorhexidine acetate were 101.18%and 98.74%with RSDs of 0.79%and 0.94%(n=9),respectively.The RSDs of the above two components in the durability test were 0.95%and 1.37%(n=9),respectively.Conclusion The method has strong specificity,high accuracy,good repeatability and durability,which can be used to improve the quality standard of Dental Ulcer Oil.

关 键 词：口腔溃疡油 高效液相色谱法 盐酸达克罗宁 醋酸氯己定 含量测定 

分 类 号：R927.2[医药卫生—药学] R988.2