HPLC同时检测姜黄素-胡椒碱复方自微乳中姜黄素和胡椒碱的含量  

Simultaneous determination of curcumin and piperine in curcumin- piperine compound self-microemulsifying drug delivery system by HPLC

作　　者：李秋萍[1] 郗砚彬 翟文文[1] 蒋俏丽 戴俊东[1] 

机构地区：[1]北京中医药大学中药学院,北京100102 [2]华润医药集团战略研发部,北京100020

出　　处：《药物分析杂志》2014年第11期1964-1968,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：北京中医药大学复方中药制剂研究创新团队发展计划资助(2011-CXTD-13);北京中医药大学自主选题项目资助(2014-JYBZZ-XS-087)

摘　　要：目的：建立在同一色谱条件下同时检测姜黄素-胡椒碱复方自微乳中姜黄素和胡椒碱含量的HPLC含量测定方法。方法：采用Purospher STAR LP C18色谱柱（4.6 mm×250 mm,5μm）,以乙腈-4%醋酸水溶液（55∶45）为流动相,流速1 mL·min^-1,检测波长342 nm,柱温30℃,进样量5μL。结果：姜黄素和胡椒碱浓度分别在20.2～80.8μg·mL^-1和0.408～1.632μg·mL^-1范围内线性关系良好;低、中、高3种浓度的平均加样回收率（n=9）分别为98.68%、98.99%、99.38%和98.40%、98.79%、99.48%,RSD分别为1.2%、0.66%、0.79%和0.69%、0.25%、0.95%;以标示量计算的平均含量分别为（43.40±0.55）mg·g^-1和（0.767±0.004）mg·g^-1。结论：经方法学验证,该方法是控制姜黄素-胡椒碱复方制剂内在质量的理想方法,适合复方自微乳中姜黄素和胡椒碱的含量测定。Objective： To establish an HPLC method for the simultaneous determination of the contents of curcumin and piperine in curcumin- piperine compound self- microemulsifying drug delivery system（ Cur- PIP-SMEDDS）. Methods： The determination was performed on a Purospher STAR LP C18column（ 4. 6 mm × 250 mm,5 μm） with a mobile phase of acetonitrile- 4% acetic acid（ 55∶ 45）. The process was carried out with the flow rate of 1. 0 mL·min^-1,the wavelength at 342 nm and the column temperature at 30 ℃. A 5 μL aliquot was injected into HPLC for analysis. Results： Good linearities of curcumin and piperine were achieved in the concentration ranges of 20. 2- 80. 8 μg·mL^-1and 0. 408- 1. 632 μg·mL^-1,respectively. The average recoveries（ n = 9） of curcumin and piperine were 98. 68%,98. 99%,99. 38% and 98. 40%,98. 79%,99. 48%,respectively,and the relative standard deviations were 1. 2%,0. 66%,0. 79% and 0. 69%,0. 25%,0. 95%,respectively,at three different levels of concentrations. The mean contents of curcumin and piperine were（ 43. 40 ± 0. 55） mg·g^-1and（ 0. 767 ±0. 004） mg·g^-1,respectively. Conclusion： The determination method is proved to be ideal to control the inner quality of Cur- PIP- SMEDDS by methodological verification and suitable for content determination of curcumin and piperine in Cur- PIP- SMEDDS.

关 键 词：姜黄素 胡椒碱 复方自微乳药物制剂 高效液相色谱 方法验证 自微乳给药系统(SMEDDS)质量控制 

分 类 号：R917[医药卫生—药物分析学]