摘要
目的建立蒲地蓝消炎口服液的质量控制方法。方法采用薄层色谱法定性鉴别,展开剂为三氯甲烷-甲醇-甲酸(9∶1∶0.5),置紫外光灯(365 nm)下检视。采用反相高效液相色谱法测定蒲地蓝消炎口服液中咖啡酸的含量,流动相为甲醇-磷酸盐缓冲液(取磷酸二氢钠1.56 g,加水使溶解成1 000 mL,再加1%磷酸溶液调节pH值至3.8～4.0),检测波长为323 nm,柱温40℃。结果薄层色谱中供试品在与对照品色谱相应的位置上显相同颜色的斑点。咖啡酸在一定色谱条件下能够完全分离,咖啡酸线性范围8.95～53.7μg.mL-1,平均加样回收率为99.99%;RSD为0.35%。结论本方法简便快捷,稳定性高,重现性好,可有效地控制蒲地蓝消炎口服液的质量。
Objective To establish a method for the quality control of Pudilan Xiaoyan Oral Liquid. Methods TLC was used in qualitative analysis and the chromatographic condition was as follows ：trichlormethane -methyl alcohol -formic acid（ 9： 1 ： 0.5 ） as developing agent, to view by ultraviolet （ 365 nm ）. The content of caffeic acid in Pudilan Xiaoyan Oral Liquid was de- termined by RP - HPLC with methanol - bufer phosphate （ taking natirum biphosphoricum 1.56 g to dissolve into water to 1 000 mL, and again adding 1% phosphoric acid to adjust pH value to 3.8 - 4.0 ） as mobile phase. The detection wavelength was 323 nm and the column temperature was 40 ~C. Results Caffeic acid could be isolated completely at a certain chromatographic con- dition, the linear range of caffeic acid was 8.95- 53.7μg · mL^ - 1, the average recovery was 99.57% with RSD of 1.29%. Con clusion This method was convenient, with good stability and reproducibility, and can be used for the quality control of Pudilan Xiaoyan Oral Liquid.
出处
《齐鲁药事》
2012年第2期75-77,共3页
qilu pharmaceutical affairs
