HPLC法测定阿扎胞苷原料药中的有关物质

摘要

Objective: To esta blish a HPLC method for the determination of the related substances of azacitidine. Methods: The separation for degradation and process impurities was based on a Waters At_lantis T3 (150 mm ×4.6 mm, 3μm) column; the Mobile phase contisted of potassium dihydrogen phosphate solution (adjust to pH 6.5)-60%acetonitrile with gradient elution; the detective wavelength was 214 nm. Re_sults: The chief peak and every impurity peak were separated well. A good linearity for azacitidine was obtained over the range of 0.2707~16.2420μg·mL-1 (r=0.9999), the LOD was 150 ng·mL-1. Conclusion:This highly selective and reproducible HPLC method offers an option in the quality control of azacitidine.%目的：建立阿扎胞苷有关物质的HPLC测定方法。方法：采用Waters Atlantis T3柱（150 mm×4.6 mm，3μm）对降解杂质和工艺杂质进行定量分析。以磷酸二氢钾缓冲液（pH=6.5）-60%乙腈为流动相，梯度洗脱；检测波长为214 nm。结果：主峰与各杂质峰间能达到基线分离。阿扎胞苷浓度在0.271~16.242μg·mL-1范围内与峰面积呈良好的线性关系（r=0.9999），最低检测限为150 ng·mL-1。结论：应用高效液相色谱法选择性高、重现性好，可作为阿扎胞苷质量控制的方法。