离子对-反相高效液相色谱法测定苄达赖氨酸及其滴眼液的含量  

An Ion-Pair RP-HPLC Determination of Bendazac Lysine and Bendazac Lysine Eye Drops

作　　者：徐宏祥[1] 胡正国 

机构地区：[1]浙江省嘉兴市药品检验所,嘉兴314001 [2]浙江平湖制药厂,平湖314200

出　　处：《药物分析杂志》2000年第4期243-245,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的 :研究离子对 -反相高效液相色谱法测定苄达赖氨酸及其滴眼液的含量 ,增加质量控制手段。方法 :采用庚烷磺酸钠作反离子 ,AlltimaC18色谱柱 ,以甲醇 -水 -冰醋酸 (6 4∶36∶0 5 ) ,内含 0 5mmol·L-1庚烷磺酸钠为流动相 ,紫外检测波长 30 7nm ,流速 1 0mL·min-1,柱温 30℃。结果 :在 30～ 2 0 0 μg·mL-1浓度范围内呈良好线性 ,最低检测浓度为 0 5 μg·mL-1,日内、日间精密度 (RSD)分别为 0 6 % (n =4)和 0 9% (n =3) ,平均加样回收率为 10 1 7% ,RSD =0 8% (n =5 )。结论 :该方法分析速度快 ,操作简便 ,准确 ,灵敏度高 ,专属性好 。Objective:Study on an ion- pair RP- HPLC method for the determination of bendazac lysine and its eye drops to provide the method of quality control Method:A sodium octanesulfonate was selected as a counter ion The assay was conducted on Alltima C 18 column with a mobile phase of methanol -water-glacial acetic acid (64∶36∶0 5) containning 0 5 mmol·L -1 sodium octanesulfonate UV detection at 307 nm Flow rate was 1 0 mL· min -1 and column temperature at 30 ℃ Results:The linear range was 30～200 μg·mL -1 ( r = 0 999 9) The lowst limit of detection was 0 5 μg·mL -1 The RSD s of between- day and intra-day were 0 6%( n = 4) and 0 9%( n =3),respectively The mean recovery was 101 7%, RSD =0 8%( n =5) Conclusion:The method is simple, quick, sensitive, and accurate for the determination of bendazac lysine in its eye drops

关 键 词：苄达赖氨酸 苄达赖氨酸滴眼液 含量测定 RP-HPLC 

分 类 号：R988.1[医药卫生—药品] R927.2[医药卫生—药学]