摘要
目的:建立HPLC法测定注射用奥扎格雷钠的含量。方法:采用Agilent ZORBAX Eclipse XDB-C_(18)色谱柱(150 mm×4.6 mm,5μm),以磷酸二氢钾缓冲液-乙腈(91:9)为流动相,检测波长为274 nm,流速为1.0 ml·min^(-1)。结果:奥扎格雷在8～120μg·ml^(-1)范围内,线性关系良好,r=0.9999(n=6),平均回收率为100.2%,RSD为0.4%(n=9)。结论:该方法用于注射用奥扎格雷钠的含量测定,简便快速,准确度高,专属性强,能满足制剂质量标准的要求。
Objective： To establish a method for determination the content of Ozagrel Sodium for injection by HPLC. Method： The Agilent Zorbax Eclipse XDB C18 column（ 150 mm ×4.6 mm,5 μm）was used, the potassium dihydrogen phosphate buffer solution-Acetonitrile （91： 9） as mobile phase, the flow rate was 1.0 ml. min^- 1, the detection wavelength was at 274 nm. Result： The linear range of Ozagrel was 8 - 120 μg· ml^ - 1 （ r = 0.999 9 ）. The average recovery was 100.2% with RSD 0. 4% （ n = 9 ）. Conclusion ： The method is specific, accurate and convenient. It can he used for quality control of Ozagrel sodium for injection.
出处
《中国药师》
CAS
2007年第4期348-350,共3页
China Pharmacist
