阿托伐他汀钙体外质量一致性评价及含量快速测定

Consistency Evaluation in Vitro Quality and Rapid Determination of Atorvastatin Calcium

建立超高效液相色谱法(UPLC)快速测定阿托伐他汀钙的含量测定方法,并对市售药品进行分析评价。用Waters Acquity BEH C18(2.1 mm×100 mm, 1.7μm);以乙腈-20 mmol·L^(-1)醋酸铵溶液52∶48为流动相;检测波长为238 nm;流速为每分钟0.35 mL;进样体积2μL。阿托伐他汀钙和阿托伐他汀钙杂质D的线性关系、精密度、稳定性、重复性良好;加样回收率分别为100.50%和105.09%,RSD分别为2.20%和1.70%(n=6)。本方法检测时间短、准确度高、操作简单、重复性好,可为阿托伐他汀钙片的质量评价提供理论依据。

A method for rapid simultaneous determination of Atorvastatin Calcium by UPLC was established,the market products was analyzed and evaluated.The determination was Waters ACQUITY BEH C18(2.1 mm×100 mm,1.7μm)with mobile phase consisted of acetonitrile-20 mmol·L^(-1) ammonium acetate solution(52∶48)at the flow rate of 0.35 mL·min-1.The detection wavelength was set at 238 nm.The sample volume was 2μL.The linear relationship,precision,stability and repeatability of atorvastatin calcium and atorvastatin calcium impurity D were good.The dosing recoveries were 100.50%and 105.09%(n=6),and the RSDs were 2.20%and 1.70%(n=6),respectively.The method was rapid,accurate,simple,good repeatability and reliable results,which could provide a theoretical basis for the quality evaluation of atorvastatin calcium.