HPLC-ELSD法测定注射用1,4-丁二磺酸腺苷蛋氨酸注射用溶剂中L-赖氨酸的含量

HPLC-ELSD method for content determination of L-lysine in the solvent used for the ademetionine 1,4-butanedisulfonate for injection

目的建立注射用1,4-丁二磺酸腺苷蛋氨酸注射用溶剂中三．赖氨酸的含量测定方法。方法采用C．。（250mm×4．6mm，5um）色谱柱，以乙腈．甲醇．0．1％Z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0．2066-2．0660μtg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（F0．9997，n=51；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三．赖氨酸含量测定的有效方法。

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, C18 column with the mobile phase consisted of acetonitrile-methanol-0.1% trifluoroacetic acid solution（2： l：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.