正相高效液相测法定碳酸钙颗粒剂中微量维生素D_3含量

Determination of contents on vitamine D_3 in the calcium carbonate effervesceing granules by HPLC

目的 :测定复方碳酸钙泡腾颗粒剂中维生素 D3 含量。 方法:用异丙醇∶水 (1∶ 1)为提取液 ,回流皂化提取制剂中维生素 D3 - β-环糊精中的维生素 D3 ,采用 Waters硅胶柱 HPL C2 6 5 nm为检测波长 ,正己烷∶异丙醇(994∶ 6 )为流动相 ,测定制剂中微量维生素 D3 含量。结果:方法回收率为 (95 .70± 2 .14) %,RSD为 2 .2 3%。日内精密度 RSD为 2 .0 7%,日间精密度 RSD为 3.76 %。 结论:该法简便、快速、专属性强 ,适用于含微量维生素 D3 制剂的质量控制要求。

Objective: To establish a method using HPLC for determination of the content of vitamine D-3. Method: The instrument was HPLC with waters silicon column (150 mm×3.9 mm,5 μm), the mobile phase was hexane-isopropand (994∶6) and the flow rate was 1 ml/min. The UV detection wavelength was 265 nm and column temperature was room temperature. Results: The calibration curve was linear (r=0.999 7) with in the range of 1.25～5 μg for vitamine D-3, the mean recovery was (95.70±2.14)%, the within-day precision RSD was 2.07% (n=5) and day-to-day precision RSD was 3.76% (n=5) at three drugs levels. Conclusion: This contents determination method is simple, quick and specific, suitable for the quality control of the drug.