Determination of ceftazidime and impurities using high performance liquid chromatography

被引:0
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作者
Jiang Enzhu [1 ,2 ,3 ]
Hu Changqin [1 ]
机构
[1] Natl Inst Control Pharmaceut & Biol Prod, Beijing 100050, Peoples R China
[2] Chinese Acad Med, Inst Med Biotechnol, Beijing 100050, Peoples R China
[3] Peking Union Med Coll, Beijing 100050, Peoples R China
关键词
high performance liquid chromatography HPLC; gradient elution; ceftazidime impurities;
D O I
暂无
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A high performance liquid chromatographic HPLC method for the determination of ceftazidime and impurities in ceftazidime drug was developed and verified. An Alltima C18 column 250 mm x 4. 6 mm 5 mu m was used as the analysis column. Acetonitrile and phosphate buffer 22. 6 g/L aqueous solution of ammonium dihydrogen phosphate adjusted to pH 3. 9 with 10% v/v phosphoric acid were used as mobile phases with gradient elution at a flow rate of 1. 3 mL/min. The column temperature was kept at 35 degrees C and the detection wavelength was set at 255 nm. Fourteen impurities could be well separated. The assay exhibited a good linearity in the ceftazidime concentration range of 0. 267 - 1 069 mu g/mL with a correlation coefficient of 1. 000 0. The limits of the quantitation and qualification of ceftazidime were 3. 1 ng and 0. 93 ng respectively. The relative standard deviations RSDs of the interday and intraday n = 3 determinations at three concentration levels were 0. 72% and 0. 91% respectively. At 4 degrees C ang under darkness ceftazidime solution was stable for 24 h. The developed method is superior to the counterparts in British and Japanese pharmacopeias in the number of the impurities separated and detected.
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页码:75 / 79
页数:5
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