【摘要】 目的建立注射用1,4-丁二磺酸腺苷蛋氨酸注射用溶剂中L-赖氨酸的含量测定方法。方法采用C18(250mm×4.6mm,5um)色谱柱,以乙腈-甲醇-0.1%三氟醋酸溶液(2:1:97)为流动相,柱温为室温,流速为1.0mL/min,以蒸发光散射检测器检测,漂移管温度:105℃,空气做为载气,流速为3.0L/min。结果在0.2066~2.0660μg范围内,色谱峰面积对数与对照品浓度的对数呈良好的线性关系(r=0.9997,n=5);平均回收率为99.78%(RSD=0.71%,n=9)。结论该法简便、可靠、专属性强、重现性好,可做为注射用1,4-丁二磺酸腺苷蛋氨酸注射用溶剂中L-赖氨酸含量测定的有效方法。更多还原

【Abstract】 Objective An HPLC-ELSD method for content determination of L-lysine in the solvent used for the ademetionine 1,4-Butanedisulfonate for injection was established. Methods The determination was performed on HPLC-ELSD, C 18 column with the mobile phase consisted of acetonitrile-methanol-0.1% trifluoroacetic acid solution(2:1:97) at room temperature. ELSD was used as detector, the drift tube temperature was 105℃ and eluant gas was air with the flow rate of 3.0L/min. Results The method showed a good liner relationship within the range of 0.2066~2.0660μg(r=0.9997, n=5). The mean recovery was 98.02% with RSD=1.05%(n=9). Conclusion The method is simple, accurate and have good reproducibility, and it could be used to content determination of L-lysine in the solvent used for the ademetionine 1,4-Butanedisulfonate for injection.更多还原