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

作　　者：李蔷薇[1] 李直[1] 王欣荣[1] 何正有[1] 姚洁[1] 李强[1] 李维[1] 

机构地区：[1]四川抗菌素工业研究所,成都610052

出　　处：《中国抗生素杂志》2013年第12期928-930,946,共4页Chinese Journal of Antibiotics

基　　金："重大新药创制"科技重大专项"国药集团技术创新产学研联盟建设"(2011ZX09401-403)

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.

关 键 词：注射用1 4 丁二磺酸腺苷蛋氨酸 三 赖氨酸 高效液相 色谱法 蒸发光散射检测器 

分 类 号：R9[医药卫生—药学]