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目的:建立高效液相色谱法测定两种奥扎格雷钠注射剂的含量。方法:采用Waters Nova-Pak C_(18)柱,以磷酸盐缓冲液—乙腈(88:12)为流动相,检测波长为272nm,室温下操作。结果;奥扎雷格钠在50～600μg·ml~(-1)范围内呈良好线性关系,r=0.9999,平均回收率为99.8％,RSD为0.5％(n=5),方法日内RSD为0.7％(n=5),日间RSD为1.0％(n=10)。结论:该方法简便、快速、专属性强,能满足制剂质量标准的要求。
Objective: To establish a HPLC method for the determination of two ozagrel sodium injection. Methods: A Waters Nova-Pak C_ (18) column was used. Phosphate buffer-acetonitrile (88:12) was used as the mobile phase. The detection wavelength was 272 nm and operated at room temperature. Results A good correlation was found between 50 and 600 μg · ml -1 of Ozarecium, r = 0.9999, with an average recovery of 99.8% and RSD of 0.5% (n = 5) 0.7% (n = 5), daytime RSD was 1.0% (n = 10). Conclusion: The method is simple, rapid and specific, which can meet the requirements of preparation quality standards.