内标法测定奥扎格雷钠颗粒的含量

Determination of ozagrel sodium granules by internal standard method

目的建立内标法测定奥扎格雷钠颗粒含量。方法采用C18柱,以0.02 mol/L乙酸铵溶液-甲醇(75∶25)为流动相,流速:1.0 mL/min,柱温:25℃,检测波长:276 nm。结果浓度在0.028～0.066 mg/mL范围内具有良好的线性关系(r=0.999 9),平均回收率为99.37%,RSD为0.92%(n=9),精密度RSD为1.07%(n=6)。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 method to determine ozagrel sodium granules by internal standard method.Methods The analysis w as conducted w ith C18 column,and the column temperature w as 25 ℃,the mobile phase consisted of 0.02 mol / L ammonium acetate solution-methanol（75∶ 25） w ith the flow rate of 1.0 mL / min,the detection w avelength w as at 276 nm.Results A good linear relationship existed in 0.028 ～ 0.066 mg / mL（r = 0.999 9）,the average recovery rate w as 99.73%,RSD = 0.92%（n = 9）,the RSD of precision w as 1.07%（n = 6）.Conclusion The method is simple,rapid,highly specific and can meet the requirements of the standard of quality of the preparations.