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目的建立HPLC法测定阿托伐他汀钙分散片的含量。方法采用Diamonsil C18色谱柱(4.6mm×250mm,5μm),以乙腈-四氢呋喃-0.05mol/L枸橼酸铵溶液(0.05mol/L枸橼酸铵溶液用氨水调pH值至4.0)(32∶18∶50)为流动相,检测波长为244nm,流速为(1.0ml/min)进样体积为20μL;柱温为30℃。结果阿托伐他汀钙在5.02～200.6μg/ml的浓度范围内呈良好的线性关系(r=0.9999,n=6),回收率为99.8%(n=9,RSD=0.40%)。结论阿托伐他汀钙分散片的含量测定的HPLC法,本方法操作简便,结果准确,能有效地控制产品质量。可用于阿托伐他汀钙分散片的含量测定。
Objective To establish an HPLC method for the determination of atorvastatin calcium dispersible tablets. Methods A Diamonsil C18 column (4.6 mm × 250 mm, 5 μm) was used. The sample was eluted with acetonitrile-tetrahydrofuran-0.05 mol / L ammonium citrate solution (0.05 mol / L ammonium citrate solution adjusted to pH 4.0 with ammonia water) 18:50) as the mobile phase, detection wavelength was 244nm, flow rate (1.0ml / min) injection volume was 20μL; column temperature was 30 ℃. Results Atorvastatin calcium had a good linearity (r = 0.9999, n = 6) in the concentration range of 5.02 ~ 200.6μg / ml. The recovery was 99.8% (n = 9, RSD = 0.40%). Conclusion HPLC method for the determination of atorvastatin calcium dispersible tablets, the method is simple, accurate and can effectively control product quality. Can be used atorvastatin calcium dispersible tablets content determination.