梯度洗脱HPLC法检查头孢他啶原料药中的有关物质

目的：建立检查头孢他啶原料药中有关物质的方法。方法：采用高效液相色谱法。色谱柱为ApolloCm以磷酸盐缓冲溶液（pH3．4）和乙腈分别为流动相A和流动相B，梯度洗脱，检测波长为254nm，流速为1．1ml／min，柱温为45oC；同时与《中国药典》方法比较检查结果。结果：本方法可分离出头孢他啶的11个相关杂质，分析时间约为30rain，出峰均匀且各峰间分离度良好，检测限为0．4ng；《中国药典》方法可分离出10个杂质，主峰前各杂质分离度不好，分析时间为55min左右。结论：与《中国药典》方法比较，本方法具有分离杂质多、分离度好、分析时间短的优点，可作为头孢他啶原料药中有关物质的分析方法。

Determination of Related Substances in Ceftazidime Raw Material Using Gradient Elution of HPLC

OBJECTIVE： To establish a method for the determination of related substances in ceftazidime raw material. METH- ODS： HPLC method was adopted. Apollo C~ column was used with phosphate buffer （pH 3.4） as mobile phase A and acetonitrile as mobile phase B （gradient elution） at the flow rate of 1.1 ml/min. The detection wavelength was set at 254 nm and the column temperation was kept at 45 ~C . It was compared with that stated in Chinese Pharmacopiea. RESULTS： By this method, 11 related impurities could be well separated, the analysis lasted for 30 min and the peaks appeared uniform and were well-separated. The lim- it of the detection was 0.4 ng. 10 impurities were isolated by the method stated in Chinese Pharmacopiea. The impurities were poor separated before main peaks appeared. The analysis lasted for 55 min. CONCLUSIONS： The method is superior than that stated in Chinese Pharmacopiea in the number of the impurities, well-separated and short analysis term, which can be used for quality con- trol method of ceftazidime raw material.