摘要
目的 建立高效液相色谱法测定阿托伐他汀钙片的溶出度.方法 采用DiamonsilC18（250mmx4.6mm,5μm）色谱柱;以醋酸铵缓冲液（pH=4.0）-乙腈-甲醇-四氢呋喃（45：35：13：7）为流动相;检测波长：244nm;流速：1.0mL·min-1;柱温：30℃.测定阿托伐他汀钙片的溶出度.结果 阿托伐他汀钙在128.2～278.5μg·mL-1范围内线性关系良好.回归方程为：y=23637x-3542,r=0.9997.辉瑞制药的立普妥和国产的阿托伐他汀钙片的溶出度均高于国家规定标准.在30min前国产阿托伐他汀钙片与辉瑞制药的立普妥的溶出度存在着不同程度的差异,立普妥溶出速度较快.结论 所建立的高效液相适用于测定阿托伐他汀钙片的溶出度.
OBJECTIVE To establish a HPLC method for the determination of dissolution of atorvastatin calci- um tablets. METHODS The chromatographic seperation was performed on Diamonsil ClS （250mmx4.6mm,5μm） column, using ammonium acetate buffer solution （ pH = 4.0） -acetonitrile-mcthanol-tetrahydrofuran （45 ： 35：13 ： 7 ） as mobile phase,detected at 244 ran. The flow rate was 1.0mL· min-1 ,the column temperature was 30℃. RESULTS The linear range was 128.2 - 278.5μL· min-1. The regression euation was y = 23637x - 3542, r = 0. 9997. It is found that the dissolution rates of Lipitor and that of atorvastatin calcium tablets were both higher than the National Standards. The results showed that there was some differences between the dissolution behavior of imported atorvasta- tin calcium tablets and that of domestic atorvastatin calcium tablets. In the early 30 mins, the dissolution rates of imported atorvastatin calcium tabletswas faster than that of domestic atorvastatin calcium tablets. CONCLUSION HPLC method is suitable for the determination of dissolution of atorvastatin calcium tablets.
出处
《海峡药学》
2013年第10期57-59,共3页
Strait Pharmaceutical Journal
