HPLC测定银杏黄酮苷元固体分散体胶囊剂的含量

Determination of the Ginkgo Flavonoid Aglycon Solid Dispersions Capsules by HPLC

目的建立高效液相色谱法(HPLC)测定银杏黄酮苷元固体分散体胶囊中有效成分的含量。方法以HypersilODS(4.6mm×150mm,5μm)为色谱柱;甲醇-4‰醋酸水溶液(48:52)为流动相;流速为0.8mL·min-1,检测波长360nm,柱温45℃。结果槲皮素和山奈素5～100μg·mL-1浓度内线性关系良好,异鼠李素在3.4～68.0μg·mL-1浓度内线性关系良好,平均加样回收率分别为99.31%,99.35%和98.18%,RSD分别为2.12%,2.28%和1.65%(n=6),精密度良好。结论本方法灵敏、准确、专属性强,可作为该制剂的含量测定方法。

OBJECTIVE A HPLC method was established to determine the content of ginkgo flavonoid aglycon solid dispersions capsules.METHODS Chromatographic condition included the Hypersil ODS column（4.6 mm×150 mm,5 μm） and mobile phase consisting of methanol-4‰ acetic acid solution（48：52）.The flow rate was 0.8 mL·min-1,the detection wavelength was set at 360 nm,the column temperature was 45 ℃.RESULTS The linear calibration curves were obtained in the concentration range of 5.0-100.0 μg·mL-1 and 3.40-68.0 μg·mL-1.The mean recovery was 99.31%,99.35% and 98.18%,RSD was 2.12%,2.28% and 1.65%（n=6） with good precision.CONCLUSION The method is sensitive,accurate and high selectivity.A satisfactory result to determine the dissolution of this dosage form was obtained with this method.