盐酸兰地洛尔原料药中3-［4-(3-硝基苯磺酰氧基)苯基］丙酸的检测方法学研究

doi:10.3976/j.issn.1002-4026.2017.02.017

Abstract

Abstract:

To detect and control the content of trace toxic impurity 3-［4-(3-nitrobenzene sulfonyl oxygen radicals) phenyl］ propionic acid, which isessential material in the synthesis of landiolol hydrochloride drug, a HPLC with tandem mass spectrometry method was developed to determine the 3-［4-(3-nitrobenzene sulfonyl oxygen radicals) phenyl］ propionic acid in the landiolol hydrochloride crude drug. The multiple reaction monitor mode was used to eliminate the matrix effect and increase the sensitivity of the method. The limit of detection of the target analyte was 0.50 mg/kg. The recoveries of spiked samples were between 91.9% and 97.8%. The relative standard diviation value of precision experiment was 3.28%(n=6). The established method was simple, reliable, fast and low cost,which is able to meet the demand of impurities determination in crude drugs.

Key words: landiolol hydrochloride, 3-［4-(3-nitrobenzene sulfonyl oxygen radicals)phenyl］propionic acid;trace detection, high performance liquid chromatography with tandem mass spectrometry

CLC Number:

O656.31

WANG Shan-shan,WANG Li-juan, LI Zhuo-wa, NING Fan-sheng,WANG Xiao-li, CHEN Yue, CHEN Xiang-feng. Study on detecting method of 3-［4-(3-nitrobenzene sulfonyl oxygen radicals) phenyl］ propionic acid in the landiolol hydrochloride crude drug[J].SHANDONG SCIENCE, 2017, 30(2): 113-120.

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Study on detecting method of 3-［4-(3-nitrobenzene sulfonyl oxygen radicals) phenyl］ propionic acid in the landiolol hydrochloride crude drug

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