HPLC法测定维生素D含量结果计算方法的研究

Investigation on the calculation methods of Vitamin D assay by HPLC

目的:对比研究HPLC法测定维生素D含量结果的计算方法。方法:通过对各国药品标准中维生素D含量计算方法的研究,并采用HPLC法对不同厂家多批次市售维生素D制剂含量进行测定和结果计算,探讨了各计算方法的优缺点。结果:提出了简化的、合理的HPLC法测定维生素D含量结果的计算方法。结论:比较和讨论了目前各国药品标准中维生素D含量计算方法的优缺点,简化后的计算方法适用范围广,简化试验操作步骤,减少误差来源,提高数据准确度,为维生素D制剂产品质量提高提供了依据。

Objective:To study and compare the calculation method of Vitamin D assay by high performance liquid chromatography(HPLC).Methods:Study on the calculation methods of Vitamin D assay in different pharmacopeias was made.The multiple batches of Vitamin D preparations from the different manufacturers were determined by HPLC,and the results were calculated.The advantages and disadvantages of the various calculation methods were discussed.Results:A simplified and reasonable calculation method of Vitamin D assay by HPLC was proposed.Conclusion:Comparison and discussion on the advantages and disadvantages of the various calculation methods in different pharmacopeias are made.The simplified calculation method is more applicable.The analytical procedure is simplified,the source of errors is reduced and the data accuracy is improved.That ensures the high quality control of Vitamin D preparations.