正相HPLC法测定碳酸钙D_3片中VD_3的含量

Determination of VD_3 Content in Calcium Carbonate D_3 Tablets by Positive Phase HPLC

目的建立正相HPLC法对VD3进行含量测定的分析方法。方法实验中采用Ultimate Si O2（4.6＊250 mm 5um）色谱柱,以正己烷-正戊醇（99∶1）为流动相;检测波长为265 nm,流速：1 m L/min,柱温：30℃。结果实验表明：该测定条件下,维生素D3标准品溶液在0.7497~1.9992μg/m L浓度范围内与其测得峰面积呈良好的线性关系,r=0.9999（n=6）,平均回收率为100.50%,精密度为0.24%。结论本方法操作简便可靠,重现性好,适合药品生产过程的质量控制。

Objective The content determination method of VD3 through positive phase HPLC was established. Method The experimental condition was listed below： Ultimate SiO2 chromatographic column （4.6＊250 mm 5 um） as stationary phase, hexane： n-pentanol （99 ： 1 ） as mobile phase, detection wavelength at 265 nm, the flow velocity at 1 mL/min, the column temperature at 30℃. Results It was showed that the content of vitamin D3 of the standard solution in the range of0.7497-1.9992 μg/mL was well propotional to the peak area of the standard solution （r=0.9999, n=6）. The average recovery of the experimental was 100.50 %, and the precision was 0.24 %. Conclusion This method is simple, reliable, reproducible and suitable for quality control of pharmaceutical production process.