高效液相色谱法测定硫酸吗啡缓释栓含量  

Determination of Morphine Sulfate Sustained Release Suppositories by HPLC

作　　者：李丹[1,2] 周本宏[1] 

机构地区：[1]武汉大学药学院,武汉430072 [2]马应龙药业集团股份有限公司

出　　处：《中国药师》2016年第2期372-374,共3页China Pharmacist

基　　金：科技部科技人员服务企业项目(编号:2009GJD10040);国家火炬计划项目(编号:2010GH021397)

摘　　要：目的:制备硫酸吗啡缓释栓剂,采用高效液相色谱法测定硫酸吗啡缓释栓剂的含量。方法:采用Eclipse XDB-C_(18)柱(150 mm×4.6mm,5μm);以甲醇-庚烷磺酸钠醋酸溶液(取庚烷磺酸钠2.02 g,加水适量溶解,加冰醋酸5 ml,加水稀释至1 000ml,摇匀)(50∶50)为流动相;流速为1.0 ml·min^(-1);检测波长:233 nm;柱温:25℃;进样量:10μl。结果:3批样品中硫酸吗啡平均含量为99.9%,在4.18~86.60μg·ml^(-1)浓度范围内线性关系良好(r=0.999 3),平均回收率100.6%,RSD=1.58%(n=9)。结论:该检测方法灵敏、快速、结果准确,适用于硫酸吗啡缓释栓剂质量控制。Objective： To prepare morphine sulfate sustained-release suppositories and determine the content by HPLC. Methods： An Eclipse XDB-C18 （150 mm × 4.6 mm,5 μm） chromatographic column was used, methanol-heptane sulfonic acid sodium acetate solution （2.02 g sodium heptanesulfonate was dissolved in appropriate amount of water and 5ml glacial acetic acid was added, and then water was added to 1000 ml, shaken up） （50：50） was used as the mobile phase, the flow rate was 1.0 ml · min-1, the detection wavelength was 233 nm, the column temperature was 25℃ and the sample size was 10 ill. Results： The average content of morphine in 3 batches of samples was 99.9%, the linear range of 4.18-86.60 μg· ml-1 was good （r =0.999 3）, and the average recovery was 100.6% （RSD = 1.58%, n =9）. Conclusion： The method is sensitive, rapid and accurate, and suitable for the quality control of morphine sulfate sustained-release suppositories.

关 键 词：硫酸吗啡 缓释栓 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]