奥拉西坦注射液中奥拉西坦2种含量测定方法的比较

Method comparison in the determination of oxiracetam injection

目的比较奥拉西坦注射液2种不同的含量测定方法。方法分别采用凯氏定氮法和HPLC法测定奥拉西坦注射液的含量。结果凯氏定氮法测定的平均回收率为99.6%,RSD为0.3%;HPLC法测定的平均回收率为99.4%,RSD为0.3%,奥拉西坦在0.020 84～0.187 56 mg.mL-1与峰面积呈良好线性关系,r=0.999 96。结论 2种测定方法的测定结果无明显差异;凯氏定氮测定法方法简便、成本低,但专属性相对较差,可用于常规检查;HPLC法专属性强、灵敏度高、重复性好,为更好的控制样品的质量,可将HPLC法订入质量标准。

Objective To compare two methods used in the determination of oxiracetam injection.Methods The contents were determined by HPLC method and Kjeldah method.Results The average recovery for Kjeldah method was 99.6%,and RSD was 0.3%.The average recovery for HPLC was 99.4%,and RSD 0.3%.Oxiracetam showed a good linear relationship within 0.020 84-0.187 56 mg·mL-1,r=0.9999 6.Conclusion There is no significant difference in the two methods.Kjeldah method is simple,with low cost but poor speciality,so it can be used as the routine method.HPLC is exclusive,reproducible,and highly sensitive,which can be used in the quality control of oxiracetam injection.