摘要
目的:采用高效液相色谱法测定米格列奈钙中的R-异构体的含量。方法:使用Sumichiral OA-3100R手性色谱柱,流动相为正己烷-氯仿-甲醇-三氟乙酸(80∶18∶2∶0.5),流速1.0 mL.min-1,检测波长259 nm,柱温35℃,进样量20μL,并考察了流动相组成、柱温和流速等色谱条件对分离的影响。结果:米格列奈钙与R-异构体,分离度为2.26,理论塔板数为5165。结论:该法简便,准确,能有效地进行米格列奈钙中的R-异构体的定量分析。
Objective： To establish an HPLC method for the determination of R-isomer in mitiglinide calcium. Methods：The chromatographer was equipped with a SUMICHIRAL OA-3100R column, with a mobile phase of a mixture of hexane-chloroform-methanol-trifluoroacetic acid （80： 18： 2：0.5 ）. The flow rate was 1.0 mL·min^-1 ;The detected wavelength was 259 nm; The temperature of the column was 35℃ ;Injection volume was 20 μL; Several parameters on column separation were studied. Result： The chromatographer equipped with the above column can separate mitiglinide calcium and its R-isomer completely, with a resolution of 2.26 and a theoretical plate number of 5165. Conclusion：This method is simple, convenient and accurate, so it can be used for determination of the R-isomer in mitiglinide calcium effectively.
出处
《药学与临床研究》
2007年第4期336-338,共3页
Pharmaceutical and Clinical Research
