盐酸莫西沙星片剂有关物质超高效液相色谱法的建立  

Establishment of UPLC Method for Determination of the Related Substances in Moxifloxacin Hydrochloride Tablets

作　　者：王立新[1] 田冶[1] 王晨[1] 张斗胜[1] 尹利辉[1] 姚尚辰[1] 崇小萌[1] WANG Li-xin;TIAN Ye;WANG Chen;ZHANG Dou-sheng;YIN Li-hui;YAO Shang-chen;CHONG Xiao-meng(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药物评价》2022年第3期194-198,共5页Chinese Journal of Drug Evaluation

摘　　要：目的:建立盐酸莫西沙星片剂有关物质超高效液相色谱法,提高检测效率。方法:采用超高效液相色谱法,色谱柱为ACQUITY UPLC BEH Phenyl(2.1 mm×100 mm,1.7μm);流动相A为四丁基硫酸氢铵缓冲液-甲醇(80∶20),流动相B为四丁基硫酸氢铵-甲醇(20∶80);进行梯度洗脱;检测波长293 nm;流速为0.4 mL·min^(-1)。结果:建立了盐酸莫西沙星片剂有关物质的超高效液相色谱法,此方法的精密度、线性及准确度较好,线性范围为0.001~1 mg·mL^(-1)。结论:此方法分离效率高,可对盐酸莫西沙星片剂中全部杂质进行有效控制。Objective:An ultra-high performance liquid chromatography method was established for the analysis of related substancesin moxifloxacin hydrochloride tablets.Methods:The analytical column was ACQUITY UPLC BEH Phenyl(2.1 mm×100 mm,1.7μm);The mobile phase A was Tetrabutylammonium hydrogen sulfate solution-methanol(8∶20).The mobile phase B was Tetrabutylammonium hydrogen sulfate solution-methanol(20∶80);gradient elution;the detected wavelength was 293 nm.The flow rate was 0.4 mL·min^(-1).Results:An ultra-high performance liquid chromatography was established for the analysis of related substance in moxifloxacin hydrochloride tablets,the precision,linearity and accuracy of this method were good,the linear range was 0.001~1 mg·min^(-1).Conclusion:This method had high separation efficiency and could effectively control all impurities in moxifloxacin hydrochloride tablet.

关 键 词：盐酸莫西沙星 有关物质 超高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]