HPLC测定脑得生固体分散体胶囊中葛根异黄酮类成分的含量

Determination of Puerarin Isoflavones in Naodesheng Solid Dispersion Capsules by HPLC

目的:建立脑得生固体分散体胶囊中葛根异黄酮类成分(葛根素、大豆苷、大豆苷元、染料木素)的含量测定方法。方法:采用高效液相色谱法,Hyspersil ODS-2色谱柱(5μm,250 mm×4.6 mm),柱温25℃,流动相甲醇-水系统梯度洗脱,流速0.8 mL·min^(-1),检测波长250 nm。结果:葛根素在0.540 8~3.244 8μg(r=0.999 9)范围,大豆苷在0.130 0~0.780 0μg(r=0.999 9)范围,大豆苷元在0.073 2~0.439 2μg(r=0.999 9)范围,染料木素在0.044 8~0.268 8μg(r=0.999 9)范围均呈良好的线性关系;平均回收率分别为99.08%,98.10%,97.91%,99.26%;RSD分别为1.67%,1.57%,2.43%,2.92%。结论:所建立方法简便、准确、重复性好,可有效控制该制剂质量。

Objective： To simultaneously determine the contents of puerarin, daidzin, daidzein and genistein in Naodesheng Solid Dispersion Capsules by HPLC. Methods： An external standard method by HPLC with Hyspersil ODS - 2 C18 column （5 μm, 250 mm ×4.6 mm） was used with the column temperature was 25 ℃. The detection wavelength was 250 nm. The flow rate was set at 0.8mL·min^-1 and gradient elution with methanol and H20. Results ： Linearities of puerarin, daidzin, daidzein and genistein were good in the ranges of 0. 540 8～ 3. 244 8μg （r = 0. 999 9）, 0.130 0 - 0. 780 0μg （ r = 0. 999 9）, 0. 073 2 - 0. 439 2μg （ r = 0. 999 9 ） and 0. 044 8 - 0. 268 8 μg （ r = 0. 999 9 ） , respectively. The average recoveries of puerarin, daidzin, daidzein and genistein were 99.08%, 98.10% , 97.91% and 99.26% and RSD values were 1.67% , 1.57% , 2.43% and 2.92% , respectively. Conclusion： The method is simple,accurate and reproducible, and can be used for quality control of Naodesheng Solid Dispersion Capsules.