Determination of ceftazidime and impurities using high performance liquid chromatography
高效液相色谱法测定头孢他啶的含量及杂质

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 microm) 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 0.267-1069 microg/mL with a correlation coefficient of 1.0000. 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.