HPLC法分离测定左炔诺孕酮片中右旋体

The Isomers in Levonorgestrel Were Isolated and Determined by HPLC

摘要: 目的：建立高效液相色谱方法，检测左炔诺孕酮及左炔诺孕酮片中右旋异构体杂质的含量。方法：采用CHIRAPAK IC (250 × 4.6 mm, 5 μm)色谱柱，流动相为异丙醇–正己烷(25:75)，流量为1.0 mL/min，检测波长237 nm，柱温30℃。结果：所建立的检测方法能有效分离左炔诺孕酮与其右旋异构体，达到基线分离，并检测左炔诺孕酮中右旋体杂质的含量。结论：该检测方法分离效果良好，简便且重复性好，可用于左炔诺孕酮原料和制剂的质量控制。

Abstract: Objective: To establish a high-performance liquid chromatography method to detect the content of levonorgestrel and levonorgestrel tablets with dextral isomer impurities. Methods: CHIRAPAK IC (250 × 4.6 mm, 5 μm) chromatographic column was used, the mobile phase was isopropanol-n-hexane (25:75), the flow rate was 1.0 mL/min, the detection wavelength was 237 nm, and the column temperature was 30˚C. Results: The established detection method could effectively separate levonorgestrel from its dextro isomer to achieve baseline separation, and detect the content of dextral impurities in levonorgestrel. Conclusion: This detection method has good separation effect, simplicity and good reproducibility, and can be used for quality control of levonorgestrel raw materials and preparations.