摘要
目的:建立鼻炎灵胶囊的质量控制方法。方法:采用Waters Symmetry C18色谱柱(250mm×4.6mm,5μm),流动相:1%甲酸水溶液(A)-甲醇(B)、梯度洗脱,0~8min:10%B,8~15min:10%→35%B,15~38min:35%→60%B,38~50min:60%→90%B,50~60min:90%B。检测波长276、327nm,流速1.0ml/min,柱温30℃。对10批鼻炎灵胶囊进行分析,测定了绿原酸和黄芩苷两个有效成分的含量,建立鼻炎灵胶囊的指纹图谱,并计算相似度。结果:两种主要成分的含量测定方法有良好的线性、精密度、重复性、稳定性和准确度,各批次鼻炎灵胶囊的指纹图谱相似度良好(〉0.95)。结论:建立的HPLC法操作简单,重复性好,精密度高,可用于鼻炎灵胶囊的质量控制。
Objective: To establish a quality control method for Biyanling capsule. Methods: The separation was carried out on a Waters Symmetry C18 column(250 mm× 4.6 mm,5 μm). The mobile phase was composed of 1% formic acid(A) and methanol(B) in gradient elution at a flow rate of 1.0 ml/min, 0-8 min:10% B,8-15 min..10%→35% B,15-38 min:35%→60% B, 38-50 min: 60%→90% B, 50-60 min.. 90 % B. The detection wavelength was set at 276 and 327 nm. The column temperature was 30 ℃. The HPLC method was applied to simultaneously determine the contents of baicalin and chlorogenic acid and develop fingerprints of 10 batches of Biyanling capsules. Results: The linearity, precision, repeatability, stability and accuracy of this method were all good. The similarity degrees of fingerprints were all fine as well (〉0.95). Conclusion: The HPLC method was simple,reproducible,accurate,and could be used for the quality control of Biyanling capsules.
出处
《药学服务与研究》
CAS
2016年第3期196-199,共4页
Pharmaceutical Care and Research
关键词
鼻炎灵胶囊
绿原酸
黄芩苷
指纹图谱
色谱法
高效液相
Biyanling capsule
chlorogenic acid
baicalin
fingerprint
chromatography, high performance liquid