目的 建立高效液相色谱（HPLC）法测定瑞舒伐他汀钙原料药中有关物质的方法。方法 采用HPLC法，Phenomenex Luna C₁₈ (2)色谱柱（250 mm×4.6 mm，5 μm），流动相为水-乙腈-1%三氟乙酸水溶液（62：37：1），体积流量为1.0 mL/min，柱温为40℃，进样量为20 μL，检测波长为242 nm。结果 系统和方法精密度RSD值均小于20%（n=6），瑞舒伐他汀钙在0.020 1～0.201 3 μg线性关系良好（r=0.999 8），瑞舒伐他汀钙的检测限为2.76 ng，各杂质氧化产物、内酯、光降解产物Ⅰ和Ⅱ和非对映异构体各杂质的检测限依次为1.85、1.32、1.08、1.11、2.06 ng。结论 本法合理严谨，精密度好，检测灵敏度高，可有效用于瑞舒伐他汀钙有关物质检测。

Objective To establish an HPLC method for detecting the related substances of rosuvastatin calcium.Methods HPLC was carried out on Phenomenex Luna C₁₈ (2) column (250 mm × 4.6 mm, 5 μm) with water-acetonitrile-1% trifluoroacetic acid (62:37:1) as mobile phase. The detection wavelength was 242 nm and injection volume was 20 μL at the flow rate of 1.0 mL/min. The column temperature was set for 40℃. Results The RSD values of method precision and system precision were less than 20% (n=6). The rosuvastatin calcium had a good linearity in the range of 0.020 1 μg-0.201 3 μg (r=0.999 8). The detection limit of rosuvastatin calcium was 2.76 ng and the detection limits of impurity were oxidation product (1.85 ng), rosuvastatin lactone (1.32 ng), photodegradation productⅠ (1.08 ng), photodegradation product Ⅱ (1.11 ng), non enantiomer (2.06 ng), respectively. Conclusion The method with good precision and high sensitivity could be used for detecting the related substances of rosuvastatin calcium.

国家科技重大专项资助项目（2011ZX09203-002)