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目的:建立注射用奥美拉唑钠有关物质检查方法。方法:采用高效液相色谱法,色谱柱为C18,流动相为硫酸氢四丁基溶液(取硫酸氢四丁基铵6.78g与氢氧化钠0.8g,加磷酸盐缓冲液(PH7.4)溶解并稀释至1000ml)-磷酸盐缓冲液(PH7.4)(磷酸二氢钠与磷酸氢二钠,加水溶解并稀释至1000ml,调节PH值至7.4)-乙腈(5:69:26),流速为1.0m/min,检测波长为280nm。结果:奥美拉唑钠主峰与包括降解产物奥美拉唑磺酰化物(5-甲氧基-2-{[(4-甲氧基-3,5-二甲基-2-吡啶基)-甲基]-磺酰基}1H-苯并咪唑)在内的其他杂质均可有效分离,峰纯度符合规定,物料平衡。结论:建立的方法准确可行,适用于注射用奥美拉唑钠的质量控制。
Objective: To establish a method for the determination of omeprazole sodium for injection. Methods: High performance liquid chromatography (HPLC) was used with C18 column and the mobile phase consisted of tetrabutyl sulfate solution (6.78 g of tetrabutylammonium hydrogen sulfate and 0.8 g of sodium hydroxide, and phosphate buffer solution (pH 7.4) Dissolved and diluted to 1000 ml) - Phosphate buffer (pH 7.4) (sodium phosphate monobasic and disodium phosphate, dissolved in water and diluted to 1000 ml, adjusted to pH 7.4) - acetonitrile (5:69:26) The flow rate was 1.0 m / min and the detection wavelength was 280 nm. Results: The main peak of omeprazole sodium is related to the degradation of omeprazole sulfonate (5-methoxy-2 - {[(4-methoxy-3,5-dimethyl-2-pyridyl) - methyl] -sulfonyl} 1H-benzimidazole) can be effectively separated, the peak purity in line with the provisions of the material balance. Conclusion: The established method is accurate and feasible and suitable for the quality control of omeprazole sodium for injection.