手性固定相HPLC法测定阿托伐他汀钙片中对映异构体的含量

Content Determination of Enantiomer in Atorvastatin Calcium Tablet by HPLC Using Chiral Stationary Phase

目的:建立测定阿托伐他汀钙片中对映异构体含量的方法。方法:采用手性固定相高效液相色谱法。色谱柱为Chiral-pakAD-H手性柱,流动相为正己烷-无水乙醇-三氟乙酸(93:7:0.1,V/V/V),检测波长为246nm,流速为1ml/min,柱温为30℃,进样量为10μl。结果:对映异构体检测质量浓度在0.63～3.15μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.9998);平均加样回收率为102.07%,RSD=1.53%(n=9);4批试样和1批市售样品均未检出对映异构体。结论:该方法专属性强、重复性好、准确度高,适用于阿托伐他汀钙片中对映异构体的检测。

OBJECTIVE： To establish a method for the content determination of the enantiomer in Atorvastatin calcium tablet. METHODS： Chiral stationary phase HPLC was adopted. The determination was performed on Chiralpak AD-H chiral column with mobile phase consisted of hexane-dehydrated alcohol-trifluoroacetic acid （93：7：0.1, V/V/V） at the flow rate of 1 ml/min. The detec- tive wavelength was set at 246 nm, and column temperature was 30℃. The sample size was 10μl. RESULTS： The linear range of enantiomer was 0.63-3.15 gg/ml （r=0.999 8） with an average recovery of 102.07% （RSD=l.53%, n=9）; None of enantiomer was found in 4 batches of samples and 1 batches of market samples. CONCLUSION： The method is specific, reproducible and accurate, and it is suitable for the determination of enantiomer in Atorvastatin calcium tablet.