目的: 建立HPLC 法测定复方氨基酸注射液(18AA-Ⅱ) 中2-磺基色氨酸的含量,并对2019年国家评价性抽验的国内7家企业155批产品进行分析。方法: 采用Waters Atlantis T3色谱柱(250 mm×4.6 mm,5 μm),以磷酸盐缓冲液-甲醇(94∶6)为流动相A,磷酸盐缓冲液-甲醇-乙腈(60∶6∶34)为流动相B,梯度洗脱,流速1.0 mL·min-1,柱温40 ℃,检测波长为220 nm,进样量10 μL。结果: 经方法学实验证明该测定方法准确可靠,2-磺基色氨酸在0.07~2.8 μg·mL-1范围内其质量浓度与峰面积线性关系良好(Y=187 014X+1 093,r=1.000);加样回收率(n=9)为98.9%~102.9%,RSD为1.6%,连续进样精密度、溶液稳定性、专属性均良好。经方法学验证实验证明测定方法准确可靠,线性关系良好,回收率和灵敏度满足试验要求,精密度、稳定性、专属性均良好。结论: 本法可以有效地测定复方氨基酸注射液(18AA-Ⅱ)中2-磺基色氨酸的含量,从而更好地控制复方氨基酸注射液类药品的质量。
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