HPLC法分离测定左炔诺孕酮中右旋异构体

摘要

Objective:To establish a chiral stationary phase-HPLC method for the enantiomer separation of norgestrel and determination of optical isomer impurities in levonorgestrel.Methods: The chiral separations were performed on CHIRALPAK IC ( 4.6 mm ×250 mm,5 μm) chiral column with the mobile phase consisted of hexane-alcohol(75:25) at a flow rate of 1.0 mL· min-1,the column temperature was set at 25℃,and the detective wavelength was 237 nm.Results:The enantiomers of norgestrel were successfully sepa-rated and optical isomer impurities in levonorgestrel were determined.Conclusion:The study provides a simple and reproducible meth-od for the quality control of levonorgestrel and its preparations.%目的：建立手性固定相拆分炔诺孕酮的高效液相色谱法，检查左炔诺孕酮中右旋异构体杂质的含量。方法：采用CHIRALPAK IC（4.6 mm ×250 mm，5μm）手性色谱柱，流动相为正己烷-无水乙醇（75∶25），流量为1.0 mL· min-1，检测波长237 nm，柱温25℃，并考察了影响分离的因素。结果：所建方法使炔诺孕酮对映体达到基线分离，可检测左炔诺孕酮中右旋异构体杂质含量。结论：所建方法简便，重复性好，可用于左炔诺孕酮原料和制剂的质量控制。