HPLC法测定注射用雷贝拉唑钠含量  

Content determination of Rabeprazole Sodium for Injection by HPLC

作　　者：王淑玲 倪辉 苏梅 周玉香 李敬芝 何杨 

机构地区：[1]江苏柯菲平医药股份有限公司,江苏南京210016

出　　处：《现代医药卫生》2016年第15期2306-2309,共4页Journal of Modern Medicine & Health

摘　　要：目的：建立一种高效液相色谱（HPLC）法，测定注射用雷贝拉唑钠的含量。方法采用HPLC法，以0.01 mol/L磷酸氢二钾缓冲液（pH 7.0）-甲醇（53∶47）作为流动相，检测波长为284 nm，流速为1.0 mL/min，柱温为25℃，测定注射用雷贝拉唑钠的含量。结果雷贝拉唑钠浓度在19.968～199.680μg/mL时线性关系良好[Y=21.8035X-17.3734，相关系数（r）=1.0000]，注射用雷贝拉唑钠高、中、低3种浓度平均回收率（n=9）为99.9%[相对标准偏差（RSD）为0.08%]，中间精密度试验的RSD为0.30%（n=6），重复性和耐用性良好。HPLC法测得3批（S28-140101、S28-140102、S28-140103）注射用雷贝拉唑钠的含量分别为101.3%、99.7%、100.1%。结论 HPLC法简便、灵敏、准确，可作为注射用雷贝拉唑钠含量的检验方法。Objective To establish a HPLC method for the content determination of Rabeprazole Sodium for Injection. Methods The high-performance liquid chromatography（HPLC） was adopted with 0.01 mol/L dipotassium hydrogen phosphate buffer solution（pH7.0）-methanol（53∶47） as the mobile phase,the detection wave length was 284 nm,the flow rate was 1.0 mL/min, the column temperature was 25℃. The content of Rabeprazole Sodium for Injection was detected. Results The rabeprazole sodi um concentration in the range of 19.968-199.680μg/mL has a good linear relationship（Y=21.803 5X-17.373 4,r=1.000 0）,the average recovery rates of high,middle and low concentrations （n=9）were 99.9%[relative standard deviation （RSD）=0.08%];the in termediate precision RSD was 0.30%（n=6）,the repeatability and durability were good. The contents of 3 batches of Rabeprazole Sodium for Injection（S28-140101,S28-140102,S28-140103）detected by HPLC were 101.3%,99.7%and 100.1%respectively. Conclusion The established HPLC method is simple,sensitive and accurate,which is suitable for the content determination of Rabeprazole Sodium for Injection.

关 键 词：苯咪唑类 药用制剂 色谱法 高压液相 质量控制 雷贝拉唑钠 

分 类 号：R57[医药卫生—消化系统]