摘要
目的建立复方制剂瑞格列奈二甲双胍片中瑞格列奈有关物质的检查方法。方法采用HPLC法测定。色谱柱为Agilent ZORBAX SB-C8柱(150 mm×4.6 mm,5μm);以磷酸盐缓冲溶液(p H=3.2)-乙腈(体积比30∶70)为流动相进行梯度洗脱,流速为1.5 m L·min-1;采用荧光检测器,激发波长为244 nm,发射波长为348 nm。结果瑞格列奈与有关物质A(4-羧甲基-2-乙氧基苯甲酸)、有关物质B(2-(3-乙氧基-4-(乙氧羰基)苯基)乙酸)和有关物质D(2-乙氧基-4-[2-[[(1S)-3-甲基-1-[2-(哌啶-1-基)苯基]丁基]氨基)-2-氧代乙基)苯甲酸乙酯)均能有效分离,分离度均大于1.5,且盐酸二甲双胍不干扰有关物质的测定。结论该方法适用于该复方制剂中瑞格列奈的有关物质检查。
Objective To establish a method to measure the content of related substances of repaglinide in repaglinide and metformin hydrochloride tablets. Methods The HPLC chromatographic analysis was performed on a ZORBAX Agilent SB-C8 （150 mm× 4. 6 mm,5 μm）column and the mixture of phosphate buffer solution （ pH = 3.2 ） and acetonitrile （ V： V = 30： 70） was used as the mobile phase with flow rate of 1.5 mL. min-l. The excitation and emission wavelengths of fluorescent were 244 nm and 348 nm. Results The related substances A, B, D and repaglinide in compound preparations were well separated with good reproducibility. Conclusions The method is simple, rapid, and sensitive, which can be used to control the related substances in repaglinide and metformin hydrochloride tablets.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2016年第9期723-728,共6页
Journal of Shenyang Pharmaceutical University
关键词
高效液相色谱法
瑞格列奈二甲双胍片
有关物质
荧光检测
HPLC
repaglinide and metformin hydrochloride tablet
related substance
fluorescent detection
