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Chiralpak AD-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246 nm,流速为1 ml/min,柱温为30 ℃,进样量为10μl.结果:对映异构体检测质量浓度在0.63～3.15 μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 8)；平均加样回收率为102.07％,RSD=1.53％(n=9)；4批试样和1批市售样品均来检出对映异构体.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 detective wavelength was set at 246 nm, and column temperature was 30 ℃. The sample size was 10 μl. RESULTS: The linear range of enantiomer was 0.63-3.15 μg/ml (r=0.999 8) with an average recovery of 102.07% (RSD=1.53%, 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.
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