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目的:建立降糖片质量控制标准。方法:采用高效液相法测定瑞格列奈的含量、含量均匀度和溶出度。结果:瑞格列奈质量浓度在0.0125~0.0625mg.mL-1,r=0.9998,范围内与峰面积呈良好线性关系,回收率为99.2%,RSD为1.6%(n=9),最低检测限为5.0ng,最低定量限为10.0ng,含量均匀度为5.56,45min累积溶出度为99.79%。结论:所建立降糖片的质量标准,符合相关要求。
Objective: To establish the quality control standard of hypoglycemic tablets. Methods: The content, content uniformity and dissolution of repaglinide were determined by HPLC. Results: The linear range of repaglinide was 0.0125 ~ 0.0625mg.mL-1, r = 0.9998, with a good linear relationship with the peak area. The recovery rate was 99.2% and the RSD was 1.6% (n = 9) The limit of quantification was 5.0 ng, the lowest limit of quantification was 10.0 ng, the content uniformity was 5.56 and the cumulative dissolution rate was 99.79% after 45 min. Conclusion: The quality standards of the established hypoglycemic tablets meet the relevant requirements.