摘要
目的建立降糖甲片的指纹图谱,为更好地控制制剂质量提供参考依据。方法采用HPLC法,色谱柱为Kromasil 100-5 C18色谱柱(250 mm×4.6 mm,5μm);检测波长:270 nm;柱温:40℃;流速:0.8m L·min^-1;进样量:10μL;流动相:以甲醇为流动相A,0.1%磷酸溶液为流动相B,梯度洗脱(0~18min,2%A;18~40 min,2%~5%A;40~55 min,5%~10%A;55~70 min,10%~20%A)。结果10批降糖甲片的相似度较好,均在0.90以上,得到了8个共有峰,进行了色谱峰的归属。结论本研究建立了降糖甲片的指纹图谱,此方法简便可靠,重现性好,可为制剂的质量控制提供参考。
Objective To determine the fingerprint of Jiangtangjia tablets,and to provide a scientific basis for the quality control of the preparation.Methods HPLC was performed on a Kromasil 100-5 C18(250 mm×4.6 mm,5μm)with methanol as the mobile phase A,and 0.1%phosphoric acid solution as the mobile phase B for gradient elution(0-18 min,2%A;18-40 min,2%-5%A;40-55 min,5%-10%A;55-70 min,10%-20%A).The detection wavelength was 270 nm,the column temperature was 40℃,the flow rate was 0.8 mL·min^-1,and the injection volume was 10μL.Results The similarity of 10 batches of Jiangtangjia tablet samples was obtained,and showed good similarity(all>0.90).Totally 8 common peaks were obtained.Conclusion The fingerprint of Jiangtangjia tablets is established.This method is simple,reliable and reproducible,and provides the experimental basis for the quality control of the preparation.
作者
董蓉
杜守颖
DONG Rong;DU Shou-ying(Beijing University of Chinese Medicine,Beijing 102488)
出处
《中南药学》
CAS
2020年第6期970-974,共5页
Central South Pharmacy
