屑止康胶囊质量控制方法研究

摘要

本实验建立了屑止康胶囊的质量控制方法.色谱柱:TC-C18 (4.6 mm×250 mm, 5μm);流动相:乙腈0.1％醋酸溶液;梯度洗脱:0～22 min 14:86, 22 min～27 min 98:2, 27 min～33 min 14:86;检测波长:230 nm;流速:1.0 m L/min;柱温:25℃.芍药苷进样量在0.174 0～1.045 1 g范围内进样量同色谱峰面积呈良好的线性关系;平均回收率为99.76％, RSD为1.09％ (n=6) .本研究建立的屑止康胶囊质量控制方法简单、结果稳定、重复性良好, 可以用于控制该制剂的质量.%The quality control method of Xiezhikang capsule was established.Chromatographic column:Agilent TC-C18 4.6 mm×250 mm, 5 μm);mobile phase:acetonitrile-0.1％ acetic acid solution;gradient elution conditions:0-22 min 14:86, 22 min-27 min 98:2, 27 min-33 min14:86;detection wavelength:230 nm;flow rate:1.0 mL/min;column temperature;25 ℃.The injection volume of paeoniflorin ranged from0.174 0-1.045 1 g.The average recovery was 99.76％, RSD=1.09％ (n=6).The quality standard established in this study is simple, stable and reproducible. It can be used to control the quality of Xiezhikang capsules.