ROCK2抑制剂CL121的含量测定及稳定性研究  

Determination and stability study of a novel drug CL121 for ROCK2 inhibitor

作　　者：崔洋洋 张过 尹晓莉[1] 李琳丽[1] CUI Yangyang;ZHANG Guo;YIN Xiaoli;LI Linli(Key Laboratory of Drug Targeting and Drug Delivery System of Ministry of Education,West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,610041 P.R.China)

机构地区：[1]四川大学华西药学院靶向药物与释药系统教育部重点实验室

出　　处：《华西药学杂志》2018年第5期541-543,共3页West China Journal of Pharmaceutical Sciences

基　　金：国家自然科学基金资助项目(批准号:81473140)

摘　　要：目的采用RP-HPLC法测定治疗糖尿病视网膜病变新型药物CL121的含量,并考察其稳定性。方法采用Venusil XBP-C_（18）色谱柱（250 mm×4. 6 mm,5μm）,流动相为甲醇–水（65∶35）,检测波长238. 4 nm,流速1. 0 mL·min（-1）,柱温30℃。结果 CL121与相邻的杂质能够完全分离;4～120μg·mL（-1）CL121与峰面积的线性关系良好（r=0. 9996）;低、中、高浓度样品精密度的RSD分别为1. 13%、1. 31%、1. 66%,平均加样回收率和RSD分别为98. 72%、99. 15%、99. 54%和0. 89%、0. 78%、1. 15%,重复性试验的RSD=0. 21%;CL121在高温、高湿及强光照射条件下均较稳定。结论所用方法简便快速、灵敏度高、专属性强,适用于CL121的含量测定及稳定性研究。OBJECTIVE To establish an RP-HPLC method for the determination of a novel drug CL121 for the treatment of diabetic retinopathy,and to investigate its stability. METHODS The Venusil XBP-C_（18）（250 mm × 4. 6 mm,5 μm） column was used. The mobile phase was methanol-water（65∶35） with the flow rate of 1. 0 mL·min（-1）. The UV detection wavelength was 238. 4 nm and the column temperature was 30 ℃. RESULTS Under the selected chromatographic conditions,CL121 could be effectively separated with impurities. The calibration curve was linear in the range of 4-120 μg·mL（-1）（r = 0. 9996）. Precisions of the method at different concentrations were 1. 13%,1. 31% and 1. 66%,respectively. The average recoveries were 98. 72%,99. 15%,99. 54% with the RSD of 0. 89%,0. 78%,1. 15%,respectively. The reproducibility was 0. 21%. CL121 was stable under the conditions of heat,moisture and light. CONCLUSION The method is simple,selective and accurate. It can be applied to analyze the content of CL121 and to investigate its stability.

关 键 词：糖尿病视网膜病变 CL121 Rho相关卷曲螺旋形成的蛋白激酶抑制剂 反相高效液相色谱法 专属性 含量测定 稳定性 

分 类 号：R917[医药卫生—药物分析学]