注射用头孢美唑钠的有关物质方法学研究

Methodology Study on the Related Substances in Cefmetazole Sodium for Injection

目的:建立HPLC法检查注射用头孢美唑钠有关物质的方法。方法:采用Agela XBP-C184.6mm×250mm5μm,以磷酸二氢铵溶液(5.75g磷酸二氢铵溶解在700ml水中,加25%四丁基氢氧化铵5.1ml)-甲醇-四氢呋喃(700:280:25)的混合溶液(用10%磷酸调pH4.5±0.1)为流动相,检测波长为214nm。结果:TMT和头孢美唑钠峰与相邻杂质峰分离度良好;在浓度3.2736μg/ml～4.9104μg/ml范围内,TMT浓度与峰面积呈良好的线性关系;TMT平均加样回收率为98.78%,RSD为0.12%。结论:本方法简便、快速、灵敏,可有效检测注射用头孢美唑钠中的有关物质。

Objective：To establish a HPLC method for the determination of related substances in eefmetazole sodium for injection. Methods： The HPLC conditions were as follows ： Agcla XBP - C 18 column （ 4. 6mm×250mm 5μm）. Mobile phase ： Dissolve 5.75g of monohasic ammonium phosphate in 700 ml of water,add 5.1 ml of a 25% solution of tetrabutylammonium hydroxide,280 ml of methanol, and 25 ml of tetrahydrofuran, and mix. Adjust with 10% phosphoric acid to a pH of 4. 5±0. 1, detection wavelength：214nm. Results：The TMT and cefmetazole with adjacent related substances were separated effec- tively. TMT has a good llnearity in the concentration of 3. 2736μ/ml to 4. 9104μg/ml. The average recovery of TMT is 98.78% and the RSD is 0. 12%. Conclusion：The method is simple and rapid, suitable for the quality control of compounds of cefmetazole sodium for injection.