儿童清咽解热口服液高效液相色谱指纹图谱研究

HPLC fingerprints of Ertong Qingyan Jiere oral liquid

目的建立儿童清咽解热口服液的指纹图谱,为制剂的质量控制提供参考依据。方法采用HPLC法,色谱柱为Phenomenex Gemini-C18(250 mm×4.6 mm,5μm);流动相A为乙腈,流动相B为0.2%磷酸溶液,梯度洗脱(0~15 min,3%~17%A;15~35 min,17%~28%A;35~50 min,28%A;50~65 min,28%~65%A;65~70 min,65%~95%A;70~80 min,95%A);柱温35℃;流速1.2 mL·min^-1;检测波长206 nm;进样量10μL。结果12批儿童清咽解热口服液的相似度较好,均在0.98以上,得到了12个共有峰,指认了秦皮乙素、黄芩苷、甜菊素3种成分。结论本研究建立了儿童清咽解热口服液的指纹图谱,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 establish the fingerprint of the Ertong Qingyan Jiere oral liquid,and to provide a scientific basis for the quality control of the preparation.Methods HPLC was performed on an Phenomenex Gemini-C18(250 mm×4.6 mm,5μm)with acetonitrile as the mobile phase A and 0.2%phosphoric acid solution as the mobile phase B for gradient elution(0-15 min,3%-17%A;15-35 min,17%-28%A;35-50 min,28%A;50-65 min,28%-65%A;65-70 min,65%-95%A;70-80 min,95%A).The column temperature was 35℃,with the flow rate of 1.2 mL·min^-1.The detection wavelength was 206 nm,and the injection volume was 10μL.Results The fingerprints of 12 batches of the Ertong Qingyan Jiere oral liquid samples were obtained,and showed good similarity(>0.98).Totally 12 common peaks were obtained,and esculetin,baicalin,and steviosin were identified.Conclusion The fingerprints of Ertong Qingyan Jiere oral liquid is established.The method is simple and reliable and has good reproducibility,and provides experimental basis for the quality control of the preparation.