系数倍率法同时测定注射用头孢噻肟钠-舒巴坦钠的含量

K-ratio method: an efficient way for determining the contents of cefotaxime sodium and sulbactam sodium for injection

目的：建立系数倍率法测定注射用头孢噻肟钠舒巴坦钠的含量。方法头孢噻肟和舒巴坦标准溶液在200～400 nm紫外区进行波长扫描，确定头孢噻肟和舒巴坦的最大吸收波长235 nm和258 nm为测定波长，并选择适当的测定波长对和确定K值。以0．1 mol/L NaOH为空白溶剂，利用系数倍率法测定头孢噻肟钠和舒巴坦钠的含量。结果头孢噻肟在4～16μg/mL范围内线性关系良好，回归方程为ΔA＝0．01956C＋0．00461（r＝0．9998），精密度试验RSD＝0．52％，平均回收率为101．5％，RSD＝1．4％；舒巴坦在2～8μg/mL范围内线性关系良好，回归方程为ΔA＝0．06566C＋0．00425（r＝0．9998），精密度试验RSD＝0．33％，平均回收率为103．0％，RSD＝1．4％；稳定性试验显示结果在2．5小时内稳定。结论系数倍率法简便、准确、重复性好，可用于注射用头孢噻肟钠舒巴坦钠含量的快速测定。

Objective To formulate a method for determining the contents Cefotaxime Sodium and Sulbactam Sodium for injection using K-ratio Method.Method Use ultraviolet wavelength to scan the standard solution of cefotaxime and sulbactam to get the scanning spectrum .Then determined the maximum absorption wavelength of cefotaxime and sulbactam as measuring wavelength which were 235 nm and 258 nm, and determined the wavelength pair and K , then established a standard curve to determine the content of cefotaxime sodium and sulbactam sodium using K -ratio method .Findings The experimental process was steady in 2.5 hours.The linear range of cefotaxime was 4 ~16μg/mL, ΔA=0.01956C＋0. 00461（r=0.9998.The precision of cefotaxime was good （RSD=0.52%,n=6）; The average recovery was 101.5% （RSD =1.4%,n =9） .The linear range of sulbactam was 2 ~8μg/mL, ΔA =0.06566C ＋0.00425（r =0.9998.Theprecision of sulbactam was good （RSD =0.33%,n =6）; The average recovery was 103.0% （RSD =1.4%,n =9）. Conclusion K-ratio Method is a simple,accurate, reproducible and it can be used to determinate the contents ofcefotaxime sodium and sulbactam sodium quickly .