RP-HPLC检测四乙酰基葛根素原料药中的有关物质

RP-HPLC determination of related substances of tetra-acetylated puerarin

目的:建立检测四乙酰基葛根素(TAP)原料药有关物质的方法。方法:采用RP-HPLC法,AgilentC18柱(250mm×4.6mm,5μm),以甲醇-水(56∶44)为流动相,流速1.0mL·min-1,检测波长为250nm。结果:TAP中未检出六乙酰基葛根素(HAP),五乙酰基葛根素(PAP)及未知杂质的含量均未超过1%。结论:本法简便、准确,可用于控制四乙酰基葛根素(TAP)原料药的质量。

Objective：To establish a method to determine the related substances of tetra-acetylated puerarin（TAP）.Method：RP-HPLC was adopted for the determination of the related substances of TAP.The chromatographic procedure was carried out with Agilent C18（250 mm×4.6 mm,5 μm）and methanol-water（56∶44）as mobile phase at a flow rate of 1.0 mL· min-1.The detection wavelength was set at 250 nm.Result：Hexa-acetylated puerarin（HAP）was not found in TAP,and the content of the penta-acetylated puerarin（PAP）and the unknown substances did not exceed 1%.Conclusion：The method is simple and accurate,and can be used for the quality control of tetra-acetylated puerarin.