HPLC法测定瑞舒伐他汀钙片的含量  

Determination of Rosuvastatin calcium tablets by HPLC

作　　者：江莉[1] 史道华[1] 楼永明[2] 庄波阳[2] 

机构地区：[1]福建省妇幼保健院药剂科,福州350001 [2]福建省药品检验所,福州350001

出　　处：《海峡药学》2013年第7期74-76,共3页Strait Pharmaceutical Journal

摘　　要：目的采用HPLC法建立测定瑞舒伐他汀钙片含量的方法。方法色谱柱Aglient C18柱(250mm×4.6mm,5μm),流动相为水-乙腈-1%三氟乙酸溶液(62∶37∶1),流速为0.8mL.min-1,检测波长为242nm。结果瑞舒伐他汀钙浓度在4.856～48.56μg.mL-1范围内与峰面积呈良好的线性关系,r为0.9999;瑞舒伐他汀钙回收率的平均值为100.5%,RSD=0.9%。结论本方法简便、准确可靠,可作为瑞舒伐他汀钙片的质量控制。OBJECTIVE To establish an HPLC method for determining the contents of rosuvastatin calcium tab- lets. METHODS The condition of detection were：Aglient C18 column （250mm ×4. 6mm,5μm） ,the mobile phase consisted of water, acetonitrile and 1% trifluoroacetic acid solution （62：37：1 ） at the flow rate of 0. 8mL·min^-1. The detection wavelength was 242nm. RESULTS The calibration curves were linear in the range of 4. 856 -48.56μg mL^-1 for rosuvastatin calcium （r = 0. 9999 ）. The average recoveries of rosuvastatin calcium were 100. 5% （ RSD = 0. 9% ）. CONCLUSION The method is simple,accurate,reliable and can be used for the quality control of rosuv- astatin calcium tablets.

关 键 词：瑞舒伐他汀钙 高效液相色谱法 含量 

分 类 号：R927.2[医药卫生—药学]