HPLC法测定肌苷片中的有关物质  

Determination of the Related Substances of Inosine Tablets by HPLC

作　　者：周明 李晓燕 李琦 ZHOU Ming;LI Xiao-yan;LI Qi(Hunan Provincial Institute for Drug Control,Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China)

机构地区：[1]湖南省药品检验研究院,湖南长沙410001 [2]湖南省药品质量评价工程技术研究中心,湖南长沙410001

出　　处：《海峡药学》2020年第7期65-67,共3页Strait Pharmaceutical Journal

摘　　要：目的采用HPLC法对肌苷片中的有关物质进行研究。方法色谱柱为C18柱(4.6mm×250mm,5μm)或性能相当的C18柱;流速:1.0mL·min-1;进样量:10μL;流动相:甲醇-水(10∶90);检测波长:248nm。结果肌苷、次黄嘌呤、鸟苷、腺苷的线性范围分别为0.01019~6.36956μg·mL-1、0.00301~6.01982μg·mL-1、0.00872~5.45126μg·mL-1、0.00995~6.22000μg·mL-1;回归系数r分别为0.99932、0.99939、0.99972、0.99998;检测限分别为检测限0.00318μg·mL-1、0.00075μg·mL-1、0.00272μg·mL-1、0.00995μg·mL-1。结论各有关物质峰与肌苷峰能达到有效分离,且操作方法简便、准确、稳定、专属性强,可用于肌苷片有关物质的检查。OBJECTIVE Study on determination of the related substances of Inosine Tablets by HPLC.METHODS The chromatography separation was performed on a Ultimate C18 column(4.6 mm×250 mm,5μm,or comparable C18 column) and methanol-water(10:90) as the mobile phase.The flow rate was 1.0 mL·min-1,and the volume injection was 10μL,and the detection wavelength was 248 nm.RESULTS The inosine,hypoxanthine,guanosine and adenosine all showed a good linearity at 0.01019-6.36956μg·mL-1,0.00301-6.01982μg·mL-1,0.00872-5.45126μg·mL-1 and 0.00995-6.22000μg·mL-1,respectively.The regression coefficient R were respectively 0.99932,0.99939,0.99972,0.99998 and the determination limits were 0.00318μg·mL-1,0.00075μg·mL-1,0.00272μg·mL-1,0.00995μg·mL-1,respectively.CONCLUSION The peak of related substances and inosine can be separated effectively.Moreover,the method of operation is so simple,accurate,stable,and specific that it can be used to determine the related substances o f inosine tablets.

关 键 词：肌苷 有关物质 次黄嘌呤 鸟苷 腺苷 

分 类 号：R927[医药卫生—药学]