HPLC法测定阿托伐他汀钙含量

Determination of Content of Atorvastatin Calcium by HPLC

目的:建立阿托伐他汀钙原料药含量测定方法。方法:运用HPLC法,采用对照品外标法计算。采用ZORZBAX C18柱,以3.9 g·L^(-1)柠檬酸缓冲盐(氨水调节pH=5.7)-乙腈-四氢呋喃=60∶24:16为流动相A,3.9 g·L^(-1)柠檬酸缓冲盐(氨水调节pH=5.7)-乙腈-四氢呋喃=20∶60∶20为流动相B,梯度洗脱,流速为1.0 m L·min^(-1),检测波长为244 nm,柱温25℃。结果:空白溶剂不干扰主成分检测,主成分与相邻杂质间分离度均大于1.5并达到基线分离。结论:本方法专属性强,准确度,重复性好,本方法可测定阿托伐他汀钙的含量。

Objective： To develop an HPLC method for the content of atorvastatin calcium. Methods： An HPLC method was established using the reference external standard method. The determination was carried out with ZORBAX C 18 column with a gradient elution. Dissolve 3.9 g of citric acid monohydrate in 1000 mL of water; adjust to pH 5.7 with ammonia solution. To 600 mL of this solution add 240 mL of acetonitrile and 160 mL of tetrahydrofuran as the mobile phase A, To 200 mL of this solution add 600 mL of acetonitrile and 200 mL of tetrahydrofuran as the mobile phase B; The flow rate was 1.0 mL.min＂1 the detection wavelength was 244 nm, and the column temperature was 25℃. Results： that is no blank interfere with the detection of main content. The resolutions between atorvastatin and adjacent impurities were greater than 1.5 and baseline separated. Conclusion： The established method, which is precise, reproducible and accurate, can be applied to the determination for the content of atorvastatin calcium.