HPLC法测定注射用头孢地嗪钠的含量

Determination of the Cefodizime Sodium by HPLC

目的 为注射用头孢地嗪钠与输液配伍的稳定性研究建立其含量测定的反相高效液相色谱方法.方法 采用HPLC-UV法测定,Kromasil C18柱（4.6mm×250mm,5μm）为分析柱,50mmol·L^ -1磷酸二氢钠溶液-5mmol·L^-1辛烷磺酸钠溶液- 乙腈（75：15：10）,流速为1.0mL·min-1,检测波长为262nm,茶碱为内标.结果 头孢地嗪钠在10～160μ g·mL^-1 检测浓度范围内呈良好线性关系（r=0.9999）,平均回收率为（98.69±1.40） %;日内差异RSD≤1.7%（n=5）,日间差异RSD≤1.7% （n=5）.结论 该方法操作简便、灵敏、准确,适用于头孢地嗪钠的含量的检测.

Objective To establish a HPLC method for determination of Cefodizime Sodium so as to study the stability of Cefodizime Sodium in different infusion solutions. Methods The HPLC-UV method used Kromasil C18 （4.6mm × 250mm,5 μm）column as an analytical column,a mobile phase consisted of 50 mmol · L^-1 NaHEPO4- 5mmol ·L^-1 Octanesulfnic acid sodium-acetonitrile （75：15：10）,at a flow rate of 1.0 mL · min^-1,and UV detection at 262 nm.Theophylline was used as internal standard. Results The assay was linear over the concentration range of 10 - 160 μ g ·mL^-1（r=0.9999）.The average recovery was （98.69 ±1.40）%. Intra-day and inter-day precision showed coefficients of variation within 1.7%（n=5） and 1.7%（n=5） over the three concentration levels.Conclusion The method is accurate,sensitive and simple,and can be used to detect the concentration of Cefodizime Sodium.