RP-HPLC同时测定沙那制剂不同剂型中没食子酸等5种活性成分含量

Simultaneous determination of five active ingredients including gallic acid in different dosage forms of Sana preparation by reverse-phase high-performance liquid chromatography

目的建立反相高效液相色谱法(RP-HPLC)同时测定沙那制剂中没食子酸、没食子酸甲酯、柯里拉京、番泻苷B和番泻苷A含量的方法。方法2021年1-12月,采用Phenomenex Hydro-RP 80A色谱柱(4.60 mm×250 mm,4μm),流动相为甲醇(A)-0.2%甲酸(B),梯度洗脱:0~18 min,1%~3%A;18~19 min,3%~15%A;19~40 min,15%~17%A;40~45 min,17%~25%A;45~65 min,25%~35%A;65~95 min,35%~60%A;95~96 min,60%~90%A;96~97 min;90%~1%A,流速:1.0 mL/min,柱温:35℃,检测波长270 nm。结果没食子酸、没食子酸甲酯、柯里拉京、番泻苷B和番泻苷A的线性范围分别为0.182~1.099µg(r=0.9999),0.046~0.278µg(r=0.9992),0.266~1.598µg(r=0.9994),0.172~1.036µg(r=0.9992),0.176~1.056µg(r=0.9999);平均加样回收率分别为100.02%、99.14%、99.38%、101.77%、100.92%。结论该方法准确、灵敏、可靠、重复性好,可用于沙那制剂的质量控制研究。

Objective To establish reverse-phase high-performance liquid chromatography and simultaneously determine gallic acid,methyl gallate,corilagin,Sennoside B,and Sennoside A levels in Sana preparations.Methods From January to December 2021,Phenomenex Hydro-RP 80A column(4.60 mm×250 mm,4μm)was used.Elution was conducted using mobile phases methanol(A)-0.2%formic acid(B).The following gradients were applied:1%-3%A for 0-18 minutes,3%-15%A for 18-19 minutes,15%-17%A for 19-40 minutes,17%-25%A for 40-45 minutes,25%-35%A for 45-65 minutes,35%-60%A for 65-95 minutes,60%-90%A for 95-96 minutes,90%-1%A for 96-97 minutes.The flow rate was 1.0 mL/minute.The column temperature was 35℃.The detection wavelength was 270 nm.Results The linear ranges of gallic acid,methyl gallate,corilagin,Sennoside B and Sennoside A were 0.182-1.099μg(r=0.9999),0.046-0.278μg(r=0.9992),0.266-1.598μg(r=0.9994),0.172-1.036μg(r=0.9992),and 0.176-1.056μg(r=0.9999).The average dosing recovery rates were 100.02%,99.14%,99.38%,101.77%,and 100.92%,respectively.Conclusion Reverse-phase high-performance liquid chromatography can be used for quality control of Sana preparations because of high accuracy,sensitivity,reliability,and reproduction.