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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 ,可作为该新药的含量测定方法
Objective : To develop a quantitative method for the determination of active ingredients for the quality control of new drug burn and pain relief creams. Method: After the ointment base was dissolved with petroleum ether, the residue was refluxed with acid methanol in the Soxhlet extractor for 5 h; the HPLC column length was 150 mm, the packing was 5 μm C18, and the mobile phase was acetonitrile-water (43:5 7). 0 0 45mol·L-1KH2PO4 (pH 50) and 0 0 13mol·L-1 sodium lauryl sulfate with a flow rate of 1 mL·min-1. UV detection wavelength was 346 nm. RESULTS: The linearity was good in the range of 0 0 8 to 0 40 μg injection volume; the reproducibility (n = 5) RSD was 36%; the average recovery was 99 3% and the RSD was 2 6 % (n =5 ). Three batches of samples were analyzed and the results were satisfactory. Conclusion : This method has high chromatographic separation efficiency and good specificity and can be used as a method for determining the content of the new drug.