RP-HPLC法测定洛匹那韦及其有关物质的含量  

RP-HPLC Determination of the Content of Lopinavir and Its Related Substances

作　　者：杨伟峰[1] 

机构地区：[1]浙江省药品检验所,杭州310004

出　　处：《药物分析杂志》2005年第8期940-942,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立反相高效液相色谱法测定洛匹那韦含量及其有关物质的方法。方法:采用 Alltech Allitma C\-\{18\}柱(150mm×4.6 mm,5μm),以乙腈-20 mmol·L^(-1)磷酸二氢钾溶液(pH 6.0)(58:42)为流动相,流速1.0mL·min\+\{-1\},检测波长210nm。结果:杂质及降解产物能与洛匹那韦基线分离;在19.92～159.36μg·mL^(-1)的浓度范围内与峰面积呈良好线性关系,r=0.9999(n=7);最低检测限为0.48 ng;日内 RSD 为0.29%(n=6);日间 RSD 为0.39%(n=6)。结论:本法准确、简便,适用于洛匹那韦及其有关物质的含量测定。Objective： To establish an RP - HPLC method for determination of lopinavir and its related substances. Method ：The sample was separated by Alhech Allitma C18 （150 mm ×4. 6 mm,5μm）column with acetonitrile- 20 mmol· L^-1 monopotassium phosphate（ adjusted to pH 6. 0）（58：42）as mobile phase,The flow rate was 1.0 mL · min^-1 and the detection wavelength was at 210 nm. Results：Its related substances could be separated from lopinavir. The linear range of lopinavir was 19. 92 - 159.36μg · mL^-1 , r = 0. 9999 （n = 7）. The low detected limit was 0. 48 ng. The RSD of intra - day was 0. 29% （n =6）and inter - day was 0. 39% （n =6）. Conclusion： This method is simple, accurate and suitable for the determination of lopinavir and its related substances.

关 键 词：洛匹那韦 高效液相色谱法 有关物质 含量测定 HPLC法 反相高效液相色谱法 RP 磷酸二氢钾 C18柱 检测波长 

分 类 号：R512.91[医药卫生—内科学] R927.2[医药卫生—临床医学]