HPLC法测定卡络磺钠注射液的含量及有关物质  

Determination of the content of carbazochrome sodium sulfonate injection and its related substances by HPLC

作　　者：纪标[1] 王东凯[1] 高斐[1] 徐松林[1] 刘莱[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《沈阳药科大学学报》2006年第3期159-161,168,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立HPLC法测定卡络磺钠注射液中卡络磺钠的含量及有关物质。方法采用Dia—monsil C18（200mm×4．6mm，5μm），以0．01mol·L^-1磷酸二氢铵（pH3．0）-乙醇（体积比为10：1）为流动相，流速为1．2mL·min^-1，检测波长360nm。结果卡络磺钠在50-250mg·L^-1内质量浓度与峰面积呈良好线性关系，r=0．9998。平均回收率为100．2％（n=9）。结论该方法可用于卡络磺钠注射液中卡络磺钠的含量及有关物质的测定。Objective To establish a HPLC method for the determination of carbazochrome sodium sulfonate injection and its related substances. Methods A Diamonsil Cts column（200 mm × 4.6 mm, 5 μm）was used with the mobile phase of 0.01 mol· L^-1 of NH4H2PO4 （pH 3.0）-ethanol （ V ： V = 10 ： 1 ）, the detection wavelength was set at 360 nm, the flow rate was 1.2 mL· min^-1. Results The calibration curve was linear in the concentration range of 50 -250 mg· L^- 1 （ r = 0. 999 8）. An average recovery was 100.2 % （ n = 9）. Conclusions The method is simple, sensitive, accurate and is suitable for the determination of carbazochrome sodium sulfonate and its related substances in carbazochrome sodium sulfonate injection.

关 键 词：高效液相色谱法 卡络磺钠 有关物质 含量测定 

分 类 号：R94[医药卫生—药剂学]