摘要
目的:建立反相HPLC法测定注射用甲泼尼龙琥珀酸钠的含量。方法:采用Agilent TC C18(2)(4.6 mm×250 mm,5μm)色谱柱,以水-四氢呋喃-甲酸(650∶350∶1)为流动相,流速:1.0 mL.min-1,检测波长:245 nm,柱温:30℃,进样体积:20μL。结果:琥珀酸甲泼尼龙在0.01~0.69 mg.mL-1浓度范围内呈良好线性关系(r=0.9999);平均回收率(n=9)为98.3%,RSD为0.3%。结论:本法简便、准确、重复性好,可用于注射用甲泼尼龙琥珀酸钠的含量测定。
Objective:To develop an RP-HPLC method for the determination of methylprednisolone sodium succinate for injection.Methods:An Agilent TC C18(2)column(4.6 mm×250 mm,5 μm)was adopted with a mobile phase of water-tetrahydrofuran-formic acid(650:350:1)at the flow rate of 1.0 mL·min-1.The detection wavelength was 245 nm,the column temperature was 30 ℃,and the volume of injection was 20 μL.Results:A good linear correlation of methylprednisolone hemisuccinate was observed within the range of 0.01-0.69 mg·mL-1(r=0.9999).The average recovery was 98.3% wih RSD 0.3%(n=9).Conclusion:The method is simple,accurate and repeatable,it can be used for the quality control of methylprednisolone sodium succinate for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第4期689-691,675,共4页
Chinese Journal of Pharmaceutical Analysis