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

关键词:  银杏黄酮苷元固体分散体胶囊  HPLC  含量测定

Key words:  Ginkgo flavonoid aglycon solid dispersions capsules  HPLC  content determination

摘要:

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Hypersil ODS (4.6 mm×150 mm，5 μm)为色谱柱；甲醇-4‰醋酸水溶液(48∶52)为流动相；流速为0.8 mL·min^-1，检测波长360 nm，柱温45 ℃。结果 槲皮素和山奈素5~100 μg·mL^-1浓度内线性关系良好，异鼠李素在3.4~68.0 μg·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。

Abstract:

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.