肝复康片质量标准研究

Quality Standard for Ganfukang Tablets

摘要:

目的: 建立肝复康片质量标准。 方法: 用TLC鉴别白花蛇舌草、太子参;用HPLC测定五味子中五味子醇甲含量,色谱柱为Agilent HC-C₁₈(4.6 mm×250 mm,5 μm),流动相乙腈-水(55 ∶45),流速1.0 mL ·min^-1,测定波长250 nm。 结果: 定性鉴别分离度好、重复性好、专属性强;五味子醇甲线性范围为0.112~5.644 μg(r=0.999 9),平均回收率97.03%,RSD 1.38%,精密度RSD 1.65%(n=6),重复性RSD 1.43%(n=6)。 结论: 方法可靠、准确、专属性强,可用于该制剂的质量控制。

Abstract:

Objective: To establish the quality standard for Ganfukang tablets. Method: Hedyotis difusa and Pseudostellaria were identified by TLC. Schisandrin was determinated by HPLC. The chromatographic condition was as follows: column of Agilent HC-C₁₈ (4.6 mm×250 mm, 5 μm), mobile phase consisting of acetonitrile-H₂O (55 ∶45), flow rate of 1.0 mL ·min^-1, and detection wavelength of 250 nm. Ferrous sulphate was determinated by spectrophotometry. Result: The characteristic identification by TLC was distinct and highly specific. Schisandrin was linear in the range of 0.112-5.644 μg (r=0.999 98), the average recovery was 97.03% (RSD 1.38%) with precision RSD of 1.5% (n=6), repetition RSD of 1.65% (n=6) and stability RSD of 1.43%. Conclusion: The method is reliable, accurate, specific and can be used for quality control of the production.