摘要
目的:对利可君片标准中含量测定方法进行改进。方法:在色谱条件不变的基础上,重新确定检测线、定量限,确定药物溶解方法及检测浓度。结果:测定浓度改为0.5 mg·mL^(-1),溶解方式改为60℃加热30 min,改进方法能使四个非对映异构体相互转化达到稳定平衡。结论:可实现对利可君片的快速、准确测定,为质量标准的修订提升提供依据。
Objective： To improve the method of content determination for Leucogen Tablets standards. Methods ： Based on the same chromatographic conditions, the LOD,LOQ, drug dissolution method and test concentration of Leucogen Tablets were determined anew. Results： The test concentration was changed as 0. 5 mg . mL^-1 and dissolution method was altered as heating for 30 min at 60 ℃. Conclusion： The improved method is rapid and accurate for the determination of Leucogen Tablets,. It can be provided as feasible basis for revision and upgrade of quality standard.
出处
《中国药品标准》
CAS
2015年第3期198-200,共3页
Drug Standards of China
