Abstract��OBJECTIVE To investigate the impurity profile of cloxacillin sodium for injection and study the source of major impurities. METHODS The impurities in samples from seven manufacturers were profiled by an optimized reversed-phase HPLC method and a newly established normal-phase HPLC method. The major impurities were prepared by semi preparation technology and identified by LC-QTOF-MS,1H-NMR and 13C-NMR.RESULTS Two new impurities relating with the salt-forming reaction and the purification process respectively,and four other new impurities were all successfully identified in this study.CONCLUSION The study is suitable for profiling the impurities in cloxacillin sodium for injection and is quite useful for enhancing the quality control.
The Ministry of Health of the Expert Committee for the Rational Use of Drugs. China Pharmaceutical Reference (�й�ҽʦҩʦ�ٴ���ҩָ��)[M]. Chongqing: Chongqing Publishing Group,2014:15-16.
[2]
EP 8.0 [S]. 2014:1933-1934.
[3]
USP 38 [S]. 2015:2916-2918.
[4]
JP16 [S]. 2012:668-671.
[5]
BP2014 [S]. 2014:1933-1934.
[6]
Ch. P (2010) Vol �� (�й�ҩ��2010���. ����) [S]. 2010:1019-1021.
[7]
HU C Q. Current situation and the trend in impurity control of chemical drugs[J]. Sci Sin Chim(�й���ѧ:��ѧ),2010,40(6):679-687.
[8]
G�WR�WG S,BABJ�� K M,BALOGH G,et al. Drug impurity profiling strategies [J]. Talanta,1997,44(9): 1517-1526.
[9]
Technical Requirements for Registration of Pharmaceuticals for Human Use [S]. 2011: Q3A(R2).
[10]
LIU H,JIA Z Q. Impurity profiling of cefalotin sodium by MEKC and HPLC [J]. Chin J Antibiot (�й���������־),2013,38 (12):921-927.
[11]
CHEN J,ZHONG X L,YU Y H. Determination of foscarnet sodium injection and its related substance by ion chromatography [J]. Chin Pharm J (�й�ҩѧ��־),2012,47 (20) : 1658-1660.
[12]
XIA X J,FU Z H,HUANG X X,et al.Determination of buagafuran and its related substances by gas chromatograghy[J]. Chin Pharm J (�й�ҩѧ��־),2008,43 (17) : 1349-1351.
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