HPLC法与氧化还原滴定法测定安乃近注射液中安乃近的含量比较  

Comparison of HPLC and Oxidation-reduction Titration for the Determination of Metamizole Sodium in Metamizole Sodium Injection

作　　者：兰文 刘轶 李晓燕 LAN Wen;LIU Yi;LI Xiao-yan(Hunan Institute for Drug ControL,Changsha 410001,China)

机构地区：[1]湖南省药品检验研究院,长沙410001

出　　处：《海峡药学》2018年第7期85-88,共4页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法(HPLC)测定安乃近注射液中安乃近的含量,并与氧化还原滴定法结果进行比较。方法采用C18柱,以磷酸盐缓冲液(取磷酸二氢钠6.0g,加水1000mL,加三乙胺1mL,用氢氧化钠溶液调pH至7.0)-甲醇(75∶25)为流动相,流速为1.0mL·min^(-1);检测波长254nm。结果在该色谱条件下,空白辅料、杂质峰与主峰均能有效分离,安乃近的线性范围为38.909~155.639μg·mL^(-1)(r=0.9996),平均回收率为100.43%(RSD=0.98%)。结论氧化还原滴定法测定结果明显高于HPLC法,滴定法专属性不强,滴定终点的判断人为误差较大,高效液相色谱法简单、快速、准确度好,专属性强,更适合作为安乃近注射液含量测定质量控制方法。OBJECTIVE To establish an HPLC method to determine the content of Metamizole Sodium in Metamizole Sodium Injection and compare it with the oxidation-reduction titration. METHODS The separation was per- formed on a C18 column, and phosphate buffer （dissolve 6.0g sodium dihydrogen phosphate and lmL triethylamine in 1000mL water, adjusted pH to 7.0 with sodium hydroxide solution）-methanol （75：25） as mobile phase, the flow rate was 1.0mL · min- 1. The detection wavelength was 254nm. RESULTS Blank supplements, Metamizole Sodium and their related substances could be separated well under the chromatographic conditions. The linear range was 38.909 155.639 mg· mL-2. Their average recovery was 100. 43 % （ RSD = 0. 98 % ）. CONCLUSION The results of oxi- dation-reduction titration were obviously higher than HPLC. Titration g specificity was not strong, and the judgment of titration endpoint leaded to a larger error. The HPLC method was simple, rapid, accurate, and more specific. It was more suitable for the determination and quality control of Metamizole Sodium Iniection.

关 键 词：安乃近注射液 HPLC法 氧化还原滴定法 含量测定 

分 类 号：R927[医药卫生—药学]