蒋敏阳,袁林,高国英
JIANG M in-yang,YUAN Lin,GAO Guo-ying

• 1:江苏省无锡药品检验所

摘要(Abstract)：

目的建立RP-HPLC-UV法用于盐酸雷诺嗪的含量和有关物质测定。方法采用Waters XBRIDGE C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-20 mmol·L-1磷酸二氢钾溶液(用三乙胺调节pH值至7.0)(体积比40∶60),流速为1.0 mL·min-1,检测波长为215 nm,进样量为10μL。结果盐酸雷诺嗪质量浓度在9.068~226.7 mg·L-1内线性关系良好(r=0.999 6),重复性试验RSD为0.96%,主峰与各杂质均具有较好的分离度。结论该方法快速、准确、专属性强,适用于盐酸雷诺嗪及其制剂的质量控制。
Objective To establish an HPLC-UV method for the detection of ranolzaine hydrochloride and related compounds. Methods A Waters XBRIDGE C18column( 250 mm × 4. 6 mm,5 μm) w as used; the mobile phase consisted of acetonitrile-KH2PO4solution( 20 mmol·L- 1,adjusted to pH 7. 0 with triethylamine)( V∶ V =40∶60); the flow rate was set at 1. 0 mL·min- 1and the detector w as set at 215 nm w ith an injection volume of 10 μL. Results The linear range w as 9. 068-226. 7 mg·L- 1( r =0. 999 6). The relative standard deviation for precision w as 0. 2%. The resolution betw een ranolazine and corresponding related substances w as good. Conclusions The present method is rapid,accurate,sensitive,and suitable for the quality control of ranolazine hydrochloride and its formulations.

关键词(KeyWords)： 盐酸雷诺嗪;含量测定;有关物质;高效液相色谱
ranolzaine hydrochloride;content determination;related substance;HPLC

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 蒋敏阳,袁林,高国英
JIANG M in-yang,YUAN Lin,GAO Guo-ying

DOI: 10.14066/j.cnki.cn21-1349/r.2013.11.012

参考文献(References)：

• [1]ZACHAROWSKI K,BLACKBURN B,THIEMERMANN C.Rano-lazine,a partial fatty acid oxidation inhibitor,reduces myocardial infarct size and cardiac troponin T release in the rat[J].Eur J Pharmacol,2001,418(1/2):105-110.
• [2]苗佩宏.新型抗心绞痛药物雷诺嗪的研究进展[J].国外医学:药学分册,2003,30(4):197-200.
• [3]楚刚辉,陈璐,程靖.非水滴定法测定盐酸雷诺嗪含量[J].医药导报,2007,26(8):940-941.
• [4]石杰,孔娜,吴拥军,等.化学发光法测定盐酸雷诺嗪含量[J].郑州大学学报,2009,44(4):771-773.
• [5]叶亚琳,杨雪梅,寻炟,等.RP-HPLC测定雷诺嗪含量及有关物质[J].中国新药杂志,2006,15(14):1190-1192.
• [6]李树春,黄河清,李中军.新型心绞痛药雷诺嗪的合成研究[J].中国药物化学杂志,2003,55(5):283-285.