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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 establish a reverse phase HPLC method for the determination of sodium methylprednisolone succinate for injection. Methods: The mobile phase consisted of water, tetrahydrofuran and formic acid (650: 350: 1) at a flow rate of 1.0 mL · min-1 on an Agilent TC C18 (2) (4.6 mm × 250 mm, 245 nm, column temperature: 30 ℃, injection volume: 20μL. RESULTS: Methylprednisolone succinate showed a good linearity (r = 0.9999) in the concentration range of 0.01-0.69 mg.mL-1. The average recovery was 98.3% (n = 9) and the RSD was 0.3%. Conclusion: This method is simple, accurate and reproducible. It can be used for the determination of methylprednisolone succinate in injection.