RP-HPLC法测定磷酸咯萘啶注射液含量及有关物质  

RP-HPLC determination of malaridine phosphate injection and its related substances

作　　者：高素英[1] 朱义[2] 

机构地区：[1]浙江省食品药品检验所,杭州310004 [2]杭州民生药业集团有限公司,杭州310011

出　　处：《药物分析杂志》2009年第11期1953-1955,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磷酸咯萘啶注射液含量及有关物质。方法:色谱柱为Phenomenex Luna C18柱(250mm×4.6 mm,5μm),以乙腈-0.05 mol.L-1磷酸二氢钾溶液(含0.1%三乙胺,用磷酸调节pH至3.0)(15∶85)为流动相,流速1.0 mL.min-1,检测波长为278 nm,结果:磷酸咯萘啶测定的线性范围为40.1～120.4μg.mL-1,r=1.000;最低检测限为0.8 ng;低、中、高浓度的平均回收率为99.5%,99.6%,99.5%(n=3);RSD分别为0.35%,0.30%,0.42%。日内和日间精密度的RSD分别为0.33%和0.20%。结论:本方法简便、快速,结果准确、可靠。Objective： To establish a RP-HPLC method for the determination of content and the related substances of malaridine phosphate injection. Methods： Phenomenex Luna C18 column（250mm×4.6mm, 5μm）was adopted as the stationary phase with the mobile phase of acetonitrile- 0.05 mol·L^-1 KH2PO4 solution（containing 0.1% triethylamine , adjusted to pH3.0 with phosphoric acid） （15：85） at the flow rate of 1.0 mL·min^-1 and the detection wavelength was set at 278nm. Results： The linearity was in the range of 40.1–120.4μg·mL^-1 with a regression coefficient of 1.000. The low,medium and high average recoveries of the method were 99.5%, 99.6%,99.5%（n=3）,RSDs was 0.35%, 0.30%, 0.42%. The RSDs of average contents of intra-day and inter-day were 0.33% and 0.20%, respectively. Conclusions： The method is simple, rapid and accurate.

关 键 词：磷酸咯萘啶注射液 含量测定 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]