吡喹酮注射液的含量测定及稳定性研究  

Determination and Stablity Test of Praziquantel Injection

作　　者：杨海峰[1,2] 李勇军[1,2] 金礼琴[2] 赵杉杉[1] 孙爱荣[1] 乔新月 

机构地区：[1]江苏农牧科技职业学院,泰州225300 [2]江苏倍康药业有限公司,泰州225300

出　　处：《中国畜牧兽医》2015年第11期3010-3015,共6页China Animal Husbandry & Veterinary Medicine

基　　金：江苏省高校"青蓝工程"资助项目;江苏省高等学校大学生实践创新训练计划项目(201412806004Y)

摘　　要：本试验旨在建立吡喹酮注射液中吡喹酮含量的测定方法,并考察其稳定性。采用高效液相色谱（HPLC）法测定吡喹酮注射液中吡喹酮含量。色谱条件：Diamonsil C18柱（150mm×4.6mm,5μm）,柱温25℃,流动相为乙腈—水（60∶40）,流速1.0mL/min,检测波长210nm,进样量20μL。通过影响因素试验、加速试验及长期稳定性试验考察吡喹酮注射液的稳定性。吡喹酮在6.037~90.555μg/mL范围内与峰面积呈良好的线性关系（R^2=0.9993）,平均加样回收率为99.24%,RSD为0.77%,吡喹酮注射液的平均含量为标示量的100.3%。在影响因素试验10d后吡喹酮注射液对高温（60℃）稳定,但对强光照射（4 500lx±500lx）有一定的敏感性。在加速试验6个月及长期稳定性试验24个月后,吡喹酮注射液的性状、含量等指标均无明显变化。试验结果表明,所建立的含量测定方法简便、可靠、灵敏、重复性好,可用于吡喹酮注射液的质量控制;吡喹酮注射液在室温、避光条件下存放稳定,有效期暂定为2年。The experiment was aimed to establish a method for determining the content of praziquantel in praziquantel injection and investigate its stability.HPLC method was used to determine the content of praziquantel.HPLC analysis was carried out using a Diamonsil C18 column（150mm×4.6mm,5μm）with ultraviolet detector at a wavelength of 210 nm.The column temperature was 25 ℃.The mobile phase,a mixture of acetonitrile and water（60∶40）with the flow rate of 1.0mL/min.The injection volume was 20μL.Stability of praziquantel injection was studied by stress test,accelerated stability test and long-term stability test.Excellent line relationship was obtained in the range of 6.037 to 90.555μg/mL（R^2=0.9993）.The average recovery was99.24% and RSD was 0.77%.The average content of praziquantel injection（percent of the labeled amount）was 100.3%.Praziquantel injection was stable to temperature（60 ℃）and unstable to light（4 500lx±500lx）during 10 days in stress test.No obvious changes of the appearance and content of praziquantel injection were observed during 6 months in accelerated test and24 months in long-term stability test.The results suggested that the established method was simple,sensitive and accurate with good repeatability,which could be used for quality control of praziquantel injection.It could be forecasted that praziquantel injection was stable and its period of validity was two years stored under room temperature（25 ℃）and away from light.

关 键 词：吡喹酮注射液 含量测定 稳定性 高效液相色谱 

分 类 号：S853.7[农业科学—临床兽医学]