高效液相色谱法测定烧伤止痛膏中小檗碱含量

HPLC Determination of Berberine in “Shaoshang Zhitong Ointment”

目的 :为新药烧伤止痛膏的质量控制制定一有效成分的定量测定方法。方法 :药膏基质用石油醚溶解后 ,残渣用酸性甲醇于索氏提取器内回流 5h ;HPLC柱长为 15 0mm ,填料为 5 μmC18,流动相为乙腈 -水 (43∶5 7) ,内含 0 0 45mol·L-1KH2 PO4 (pH 5 0 )和 0 0 13mol·L-1十二烷基硫酸钠 ,流速为 1mL·min-1,UV检测波长为 346nm。结果 :在进样量为 0 0 8～ 0 40 μg范围内线性关系良好 ;提取重现性 (n =5 )RSD为 3 6 % ;平均回收率为 99 3 % ,RSD为 2 6 % (n =5 )。分析了 3批样品 ,结果满意。结论 :本法色谱分离效率高、专属性好 。

Objective:To develop a quantitative method for quality control of the “Shaoshang Zhitong Ointment”.Method:The ointment was dissolved in petroleum ether and the residue was extracted by reflux 5 h with methanol-hydrochloric acid(100∶1).The chromatographic system consisted of Inertsil C 18 column and mobile phase pf MeCN-H\-2O(43∶57),0 045 mol·L -1 KH\-2PO\-4,0 013 mol·L -1 sodium laurylsulfate,a flow rate was 1 0 mL·min -1 and with a detection wavelength at 346 nm.Results:The recovery for berberine was in the range of 96\^1% to 102\^8% with RSD 2\^6(\%n=5\%) and the linear range was 0\^08 μg to 40 μg ( r=0\^999 6,n=7). Conclusion:The HPLC method is accurate and suitable for the analysis of berberine in this preparation.