HPLC测定甘糖酯片的含量和溶出度

Determination and dissolution of propylene glycol mannurate sulfate by HPLC

目的 建立测定甘糖酯片含量和体外溶出度的高效液相色谱方法。方法 采用AminexHPX 87H(30 0mm× 7.8mm)离子排阻柱 ,以 0 .0 0 5mol·L-1H2 SO4为流动相 ,柱温为 6 0℃ ,流速为 0 .5mL·min-1,用葡萄糖醛酸作内标 ,在 2 10nm波长处紫外检测 ,以内标法峰面积定量。结果 本法测定线性范围为 10 0～ 2 0 0 0 μg·mL-1,平均回收率为 97.32 % ,RSD =2 .5 4 %(n =6 ) ,最低检测限为 4 μg·mL-1。结论 本法测定甘糖酯片含量和体外溶出度 ,方法简便、快捷 ,重现性好 。

OBJECTIVE: To establish a HPLC method for the determination of propylene glycol mannurate sulfate (PGMS) and its dissolution. METHODS: Aminex HPX-87H column (300 mm × 7.8 mm) was used. 0.005 mol&middotL-1 H2SO4 was used as the mobile phase at the flow rate of 0.5 mL&middotmin-1. D-glucuronic acid was used as the internal standard. The column temperature was 60°C with the detection wavelength at 210 nm. RESULTS: The calibration curve was linear over the range of 100∼2 000 μg&middotmL-1, the average recovery was 97.32% with RSD = 2.54% (n = 6) and its detection limit was 4μg&middotmL-1. CONCLUSION: This method was proved to be simple, rapid, reliable and reproducible.