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目的:建立测定小儿复方赖氨酸颗粒中盐酸赖氨酸的定量测定方法。方法:氨基酸分析仪定量测定,色谱柱为阳离子树脂柱LCA K06/Na(150 mm×4.6 mm,7μm),以柠檬酸缓冲液A(pH 3.45)与柠檬酸缓冲液B(pH 10.85)梯度洗脱为流动相,检测波长为570 nm和440 nm,流速为0.45 ml·min~(-1)。结果:盐酸赖氨酸在2.692~21.536μg·ml~(-1)范围内与峰面积呈良好的线性关系,r=0.999 5,平均加样回收率为98.85%,RSD为0.63%(n=9)。结论:该方法灵敏度高,操作简单,重复性好,可用于小儿复方赖氨酸颗粒的质量控制。
Objective: To establish a method for the quantitative determination of lysine hydrochloride in children’s compound lysine granules. METHODS: Amino acid analyzer was used for the quantitative determination. The chromatographic column was a cation resin column LCA K06 / Na (150 mm × 4.6 mm, 7 μm). The column was washed with a gradient of citrate buffer A (pH 3.45) and citrate buffer B (pH 10.85) The mobile phase was eluted with a detection wavelength of 570 nm and 440 nm at a flow rate of 0.45 ml · min -1. Results: The linear range of lysine hydrochloride to peak area was 2.692 ~ 21.536μg · ml ~ (-1), r = 0.999 5, the average recovery was 98.85% and the RSD was 0.63% (n = 9). Conclusion: The method has high sensitivity, simple operation and good repeatability, and can be used for quality control of pediatric compound lysine granules.