泛硫乙胺颗粒含量及有关物质测定的方法学研究  

Study on Determination of Content and Related Substances of Pantethine Granule

作　　者：徐世芳[1] 陈爱瑛[1] 姜丽霞[1] 

机构地区：[1]浙江省医学科学院药物研究所,杭州310013

出　　处：《浙江省医学科学院学报》2007年第3期20-22,共3页

摘　　要：目的建立泛硫乙胺颗粒含量及有关物质的方法学研究。方法用高效液相色谱法测定泛硫乙胺颗粒中泛硫乙胺的含量，色谱柱为C18，流动相为甲醇-水（45：55），流速1．0mL／min，检测波长为UV210hm。用薄层色谱法检查有关物质，以硅胶G为薄层吸附剂，水饱和的丁酮溶液为展开剂，碘蒸气为显色剂。结果泛硫乙胺在313μg／mL-492μg／mL（n=5）范围内线性关系良好（r=0．9998）；重复性RSD为0．6％（n=6）。薄层图谱斑点清晰，空白无干扰，检测限为0．6μg。3批样品泛硫乙胺的含量为标示量的98．9％～99．5％，有关物质均小于2％。结论该方法准确、重现性好；可用于泛硫乙胺颗粒的质量控制。Objective To establish the methodology of determining of content and related substances in pantethine granule.Methods Pantethine was determined in pantethine granule by HPLC. The chromatographic system consisted of Inertsil C18 column and mobile phase of MeOH- H2O （45：55）. The flow rate was 1.0mL/min, and the detective wavelength was at 210nm.It＇s related substances in pantethine granule were detected by TLC. The plates covered with silica gel G were developed in a solvent system of water-saturated Butanone and colored with iodine vapor. Results The calibration cruve was linear in the range of 313μg/mL- 492p, g/mL （n=5）. The method was proved to be repeatable with RSD 0.6%（n=6）.The TLC sports developed were fairly clear , and the bland test showed no interference.The detection limit was 0.6μg .Three batches of sample were analyzed and the pantethine contents were 98.9%-99.5% of the label amount, and the related substances were less than 2.0%.Conclusion The method would be proved to be accurate and reliable, and could be used for the quality control of this preparation.

关 键 词：泛硫乙胺 质量标准 含量测定 有关物质 高效液相色谱法 薄层色谱法 

分 类 号：R978.1[医药卫生—药品]