摘要
目的:建立HPLC法测定注射用富马酸伊布利特的含量及有关物质。方法:采用HPLC法,SHIMADZU VP-ODS色谱柱(250mm×4.6mm,5μm);流动相:0.06mol·L-1KH2PO4(pH5.8)-甲醇-三乙胺(45∶55∶0.01);流速:1.0mL·min-1;检测波长:228nm。结果:富马酸伊布利特在0.0368～0.1472mg·mL-1范围内呈良好的线性关系(r=0.9996),最低检测限0.1ng。平均回收率为100.2%(RSD=0.4%)。结论:方法专属性好,准确、灵敏、快速,结果可靠。
Objective：To establish an HPLC method to determine the content and the related substances of ibutilide fumarate for injection Method： Use a SHIMADZU VP-ODS column （250mm×4.6mm,5μm）, with a mixture of 0.06mol.ml-1KH2PO4（pH5.8）-methanol -triethylamine（45：55：0.01） as mobile phase at the flow rate of 1.0ml.min-1.The detection wavelength was 228 nm. Results： Ibutilide fumarate had a good linear relation over the range of 0.0368～0.1472mg.ml-1 （r=0.9996）;the limit of the detection was 0.1ng ;the average recovery was 100.2% （RSD=0.4%）. Conclusion： The method is simple ,accurate ,sensitive, quickly and reliable for determination of ibutilide fumarate for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第8期1339-1341,共3页
Chinese Journal of Pharmaceutical Analysis
基金
科学技术部科技型中小企业技术创新基金(05C26113300766)
