论文部分内容阅读
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 suppository and determine the content of morphine sulfate sustained-release suppository by high performance liquid chromatography. METHODS: The sample was eluted with Eclipse XDB-C 18 column (150 mm × 4.6 mm, 5 μm). The sample was eluted with sodium heptane sulfonate (2.02 g) , Diluted with water to 1000ml, shake (50:50) as the mobile phase; flow rate of 1.0 ml · min -1; detection wavelength: 233 nm; column temperature: 25 ℃; injection volume: 10μl. Results: The average content of morphine sulfate was 99.9% in 3 batches of samples, and the linearity was good (r = 0.999 3) in the range of 4.18 ~ 86.60 μg · ml -1 with the average recovery of 100.6% and RSD = 1.58% n = 9). Conclusion: The method is sensitive, rapid and accurate. It is suitable for the quality control of morphine sulfate sustained release suppository.