RP-HPLC法测定吲哚美辛巴布膏的含量和有关物质

目的：建立RP-HPLC法测定吲哚美辛巴布膏的含量和有关物质。 方法：采用Agilent ZORBAX Eclipse Plus C₁₈色谱柱（4.6 mm×150 mm，5 μm），以甲醇-水-磷酸（600：400：1）为流动相，流速1.0 mL·min^-1，检测波长228 nm，柱温40℃。 结果：吲哚美辛浓度在0.5~10 μg·mL^-1及10~200 μg·mL^-1范围内呈良好线性关系（r=0.9999）；方法的平均回收率（n=9）为99.3%，RSD=1.1%；3批样品含量测定结果分别为98.4%、97.1%和98.2%，有关物质检查中吲哚美辛峰与各杂质分离度符合要求。 结论：经方法学验证，该方法可用于控制吲哚美辛巴布膏主药及有关物质的含量测定。

Objective: To establish an RP-HPLC method for determination of Indometacin Patch and its related substances. Methods: The column was Agilent ZORBAX Eclipse Plus C₁₈ (4.6 mm×150 mm,5 μm).The mobile phase was composed of methanol-water-phosphoric acid (600: 400: 1) at a flow rate of 1.0 mL·min^-1.The detection wavelength was 228 nm and the column temperature was 40℃. Results: The calibration curves were linear in the ranges of 0.50-100 μg·mL^-1 and 10.0-200.0 μg·mL^-1.The average recovery (n=9) was 99.3% with a RSD of 1.1%.The content determination results for the 3 batches of samples were 98.4%,97.1% and 98.2%,respectively.The resolution between indometacin and its related substances was acceptable. Conclusion: The method is suitable for determination of the content and related substances of indometacin patch according to the methodological verification.

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