RP-HPLC法测定注射用甲泼尼龙琥珀酸钠的含量

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,5 μm)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:20 μL。 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.

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[4] USP 32/NF 27,2009.2955
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