改进HPLC法同时测定注射用替卡西林钠克拉维酸钾中两种主成分的含量

摘要

目的:改进测定注射用替卡西林钠克拉维酸钾中两种主成分含量的方法.方法:采用高效液相色谱法.色谱柱为Waters XBridgeTM C18,流动相为0.01 mol/L磷酸氢二铵溶液(用磷酸调节pH至7.0)-甲醇(80:20,V/V),流速为1.0 mL/min,检测波长为220 nm,柱温为30℃,进样量为20μL.结果:替卡西林和克拉维酸的检测质量浓度线性范围分别为1.95~195.22、0.12~12.18μg/mL(r=0.9999);精密度、稳定性(4℃下放置)、重复性试验的RSD<1.0%;替卡西林和克拉维酸的加样回收率分别为99.3%~100.5%、99.2%~101.0%,RSD分别为0.4%、0.7%(n=9).结论:该方法简便快速、准确可靠,可用于注射用替卡西林钠克拉维酸钾中两种主成分含量的同时测定.%OBJECTIVE:To improve the method for the determination of 2 main components in Ticarcillin disodium and potas-sium clavulanate for injection. METHODS:HPLC was performed on the column of Waters XBridgeTM C18 with mobile phase of 0.01 mol/L ammonium dibasic phosphate solution(pH 7.0)-menthol(80:20,V/V)at a flow rate of 1.0 mL/min,the detection wave-length was 220 nm, column temperature was 30 ℃, and injection volume was 20 μL. RESULTS:The linear range was 1.95-195.22 μg/mL for ticarcillin (r=0.9999) and 0.12-12.18 μg/mL for clavulanate(r=0.9999);RSDs of precision,stability (under 4 ℃) and reproducibility tests were lower than 1.0%;recoveries were 99.3%-100.5%(RSD=0.4%,n=9) and 99.2%-101.0%(RSD=0.7%,n=9). CONCLUSIONS:The method is rapid,accurate and reliable,and can be used for the determination of 2 main components in Ticarcillin disodium and potassium clavulanate for injection.