抗病毒清热口服液高效液相指纹图谱研究及含量测定

Fingerprint and Determination of Kangbindu Qinre Oral Liquid by HPLC

目的:建立抗病毒清热口服液的指纹图谱,并进行定量分析,为评价其质量提供依据。方法:采用Waters CORTECS T3 C18柱(150 mm×4.6 mm,2.7μm);流动相为乙腈-0.4%磷酸溶液,梯度洗脱,流速:1.0 ml·min^(-1);检测波长:230 nm;柱温:30℃。结果:绿原酸及连翘苷分别在95.60~2294.20 ng及75.20~1804.20 ng范围内与相应峰面积呈良好的线性关系(r=0.9999)。绿原酸和连翘苷的平均加样回收率分别为99.3%和100.2%,RSD分别为0.9%和0.5%(n=6)。建立了抗病毒清热口服液的高效液相指纹图谱共有模式,标定了其中16个共有峰,13批抗病毒清热口服液的相似度均大于0.9。结论:所建立的高效液相指纹图谱和含量测定分析方法可用于抗病毒清热口服液的质量控制。

Objective:To establish the fingerprint and determination method for Kangbindu Qingre oral liquid to provide reference for quality evaluation.Methods:A Waters CORTECS T3 C18(150 mm×4.6 mm,2.7μm)column was adopted with acetonitrile and0.4%phosphoric acid as the mobile phase with gradient elution at a flow rate of 1.0 ml·min^(-1);the detection wavelength was230 nm;the column temperature was 30℃.Results:There was a good linear relationship for chlorogenic acid and forsythin within the range of 95.60-2294.20 ng(r=0.9999)and 75.20-1804.20 ng(r=0.9999),respectively.The average recovery of chlorogenic acid and forsythin was 99.3%(RSD=0.9%)and 100.2%(RSD=0.5%)(n=6),respectively.The common pattern of HPLC fingerprint of Kangbindu Qingre oral liquid was established,totally 16 peaks were identified,and the similarity of 13 batches of Kangbindu Qingre oral liquid was above 0.9.Conclusion:The established method can be used for the quality control of Kangbindu Qingre oral liquid.