高效液相色谱法测定螨变应原注射液中防腐剂苯酚含量

目的：建立高效液相色谱法测定螨变应原注射液中苯酚含量。方法：采用Watershed Novo-Pak C₁₈（4 μm ，3.9 mm×150 mm）色谱柱，流动相为甲醇-水（40：60），流速1.0 mL·min^-1，检测波长为270 nm。结果：苯酚浓度在21.56~107.8 μg·mL^-1范围呈良好的线性，r=0.9999；平均回收率（n=9）为99.1%。结论：本文方法经方法学验证可用于螨变应原注射液苯酚含量的测定。

Objective: To establish the HPLC method for determination of phenol in mite allergons preparation. Methods: The sample was analyzed on a Waters Novo-Pak C₁₈ column(4 μm,3.9 mm×150 mm) with the mobile phase of methanol-water (40:60);the flow rate was 1.0 mL·min^-1, and the detection wavelength was 270 nm. Results: The linear range of the phenol concentration was 21.56-107.8 μg·mL^-1,r=0.9999; and the average recovery(n=9) of phenol was 99.1%. Conclusion: This HPLC method can be applied to effective determination of phenol in mite allergons preparation,and the method meets the requirements for methodological validation.

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