摘要
目的建立了高效液相色谱梯度洗脱法测定匹伐他汀钙中有关物质的方法。方法采用C18(4.6mm×250mm,5μm)色谱柱,以醋酸盐缓冲液(取醋酸钠0.15g,冰醋酸0.5mL,加水稀释至1000mL)为流动相A,乙腈为流动相B,梯度洗脱条件:0～20min,A为56%;20～40min,A为56%→30%;40～60min,A为30%;以1.0mL.min-1的流速进行梯度洗脱;检测波长为245nm。结果匹伐他汀钙与各有关物质的分离度良好,匹伐他汀钙及杂质Ⅰ、Ⅱ、Ⅲ、Ⅴ、Ⅵ的检测限均为0.04μg.mL-1。结论所建立的方法简便、灵敏、准确,可用于匹伐他汀钙有关物质的测定。
Objective To establish an HPLC gradient elution method for the determination of the related substances in pitavastatin calcium. Methods The C18 column （4.6 min×250mm,5μm） was used. The mobile phase A consisted of acetate buffer solution and the mobile phase B of acetonitrile. The gradient elution was performed as follows： 0-20 min, A： 56%; 20-40 rain, A： 56%→30%; 40-60 rain, A： 30%. The gradient elution was performed with a flow rate of 1.0 mL·min^-1 and the detective wavelength was set at 245 nm. Results Good separation of pitavastatin calcium and its related substances was obtained. The detection limits of pitavastatin calcium and impurity Ⅰ、Ⅱ、Ⅲ、Ⅴ and Ⅵ were all @. 04μg·mL^-1 Conclusion The established method is simple, sensitive and practicable, which can be used to determinate the related substances of pitavastatin calcium.
出处
《中国药事》
CAS
2013年第6期608-612,共5页
Chinese Pharmaceutical Affairs
