RP-HPLC法测定抗病毒口服液中芒果苷和连翘苷的含量

Determination of Chimonin and Forsythiaside in Kangbingdu Oral Liquid by RP-HPLC

目的建立抗病毒口服液中芒果苷和连翘苷的含量测定方法,为抗病毒口服液质量标准的再提高提供依据。方法采用RP-HPLC法同时测定抗病毒口服液中芒果苷和连翘苷的含量。色谱柱:Kromasil RP-C18柱(4.6mm×250mm,5μm);流动相:乙腈-0.1%醋酸(15∶85);流速0.80mL·min-1;检测波长:时间-波长程序(0→25min:258nm,25→30min:277nm);理论塔板数按芒果苷计算应不低于6000,按连翘苷计算应不低于5000。结果芒果苷线性范围48.8ng～1525ng,r=0.9994;连翘苷线性范围56ng～1750ng,r=0.9995。芒果苷、连翘苷的平均回收率分别为97.65%、99.21%。10批次样品中芒果苷的含量范围在14.40～20.41μg·mL-1,连翘苷的含量范围在28.70～36.01μg·mL-1。结论该测定方法具有操作简便、稳定、专属性强、可重复的特点,可用于抗病毒口服液的质量控制。

Objective To establish a method for the determination of chimoni and forsythiaside in Kangbingdu Oral Liquid （KOL） and to develop a new quality standard for KOL. Methods A RP - HPLC method was adopted for the determination of chimonin and forsythiaside of KOL. The chromatographic conditions were as follows： Kromasil RP - C18 （250 mm × 4.6 ram, 5μm） column was used, a mixture of acetonitrile -0. 1% acetic acid （15 ： 85, v/v） served as mobile phase, the flow rate was 0. 80 mL· min^-1, and detective wavelengths of time process were 0→25 min： 258 nm, and 25→30 min： 277 nm. Theoretical plate number of chimoni was over 6000 and that of forsythiaside was over 5000. Results The ehimonin showed a good linearity in the range of 48.8ng - 1525 ng（ r = 0. 999 4）, and the linear range of forsythiaside was in the ranged of 56ng - 1750 ng （ r = 0. 999 5）. The mean recovery of ehimonin and forsythiaside was 97.65 % and 99.21% respectively. The content of chimonin in the 10 batches of samples was in the range of 14.40 - 20.41μg·mL^-1, and that of forsythiaside was in the range of 28.70 -36.01μg·mL^-1. Conclusion The developed method has been proven to be simple, stable and reproducible, and can be applied for quality control of the Kangbingdu Oral Liquid.