HPLC同时测定抗疟复方制剂中磷酸咯萘啶、磺胺多辛与乙胺嘧啶含量  

Simultaneous Determination of Malaridine,Sulfadoxine and Pyrimethamine in an Antimalarial Compound Preparation by HPLC

作　　者：陶奕[1] 张皓冰[1] 金琦芸[2] 郭幼梅[2] 张丽文[3] 

机构地区：[1]中国疾病预防控制中心寄生虫病预防控制所,上海200025 [2]复旦大学药学院,上海200032 [3]俄亥俄大学化学系,美国俄亥俄州43210

出　　处：《中国药学杂志》2006年第8期634-636,639,共4页Chinese Pharmaceutical Journal

基　　金：国家"九五"科技攻关课题(96-906-04-07)

摘　　要：目的 建立同时测定复方抗疟制剂中磷酸咯萘啶、磺胺多辛与乙胺嘧啶的高效液相色谱法.方法 醋酸-醋酸钠（pH6）-乙醇（30：70）为提取溶剂,ZORBAX RX-C18柱（4.6 mm×150mm,5 μm）,[0.022 mol·L^-1盐酸-0.22%三乙胺水溶液（pH 2.3）]-乙腈（75：25）为流动相,流速1 mL·min^-1,非那西丁为内标,266 nm为检测波长.结果 非那西丁、磷酸咯萘啶、乙胺嘧啶与磺胺多辛的保留时间分别为：10.19,1.27,5.70和7.63 min.磷酸咯萘啶、乙胺嘧啶与磺胺多辛的线性范围、相关系数分别为20～400（mg·L^-1）,r=0.999 3;2.05～40.20mg·L^-1,r=0.999 9;20.01～800.40mg·L^-1,r=0.999 9.磷酸咯萘啶、乙胺嘧啶与磺胺多辛的提取回收率和RSD（n=3）分别为（97.62±1.09）%,3.68%;（98.34±1.94）%,1.97%及（99.77±2.16）%,2.17%.结论 本方法灵敏度、准确度均能满足含量测定的需要,提取和测定快速简单,可用于该复方制剂的质量控制.OBJECTIVE To develop a high performance liquid chtromatographic（HPLC） method to determine malaridine sulfadoxine and pyrimethamine simultaneously in an antimalarial compound preperation simultaneously. METHODS Buffer（HAc-NaAc, pH 6）-EtOH（70：30） was used as extraction solvent. The chromatographic analysis was carried out using ZORBAX RX- C18 column（4.6 mm×150mm,5 μm） and mobile phase consisting of buffer[0.022 mol·L^- 1 HCl-0.22% triethylamine, pH 2.3]-ACN （75：25） at a flow rate of 1 mL·min^-1. Phenacifine was used as internal standard and all components were quantified with detection wavelength at 266 ran.RESULTS The recoveries of malaridine, sulfadoxine and pyrimethamine were （97.62 ± 1.09） % with RSD = 3.68 %, （99.77 ± 2.16） % with RSD = 2.17 % and （ 98.34 ± 1.94）% with RSD = 1.97 % （n = 3）, respectively. The linear range and regression equation of malaridine, sulfadoxine and pyrimethamine were over the range of 20± 400 mg·L^-1 with r = 0.999 3,2.05 ±40.20 mg·L^-1 with r =0.999 9 and 20.01 ± 800.40 mg·L^-1 with r = 0.999 9. The retention time for the internal standard phenacitine, malaridine, pyrimethamine and sulfadoxine were 10.19,1.27,5.70 and 7.63 rain, respectirely. CONCLUSION The method, which is simple, sensitive and precise in the determination and extraction of those three components, can meet the requirements for the quality control of the antimalarial compound preparation.

关 键 词：高效液相色谱法 磷酸咯萘啶 磺胺多辛 乙胺嘧啶 非那西丁 

分 类 号：R917[医药卫生—药物分析学]