RP-HPLC法测定甲睾酮聚乳酸微球中甲睾酮的含量

目的: 建立高效液相色谱法测定甲睾酮聚乳酸微球中甲睾酮的含量。 方法: 采用Diamonsil-C₁₈(250 mm×4.6 mm,5 μm)色谱柱,以甲醇-水(72∶28)为流动相,检测波长为241 nm,流速为1.0 mL·min^-1,进样量为10 μL,柱温为30 ℃。 结果: 甲睾酮10~115 μg·mL^-1范围内线性关系良好(r =0.9999),平均回收率(n =9)为99.5%。 结论: 所建方法简便、快捷,准确可靠,可用于甲睾酮聚乳酸微球的质量控制。

Objective: To establish a method to determine methyltestosterone in microspheres of methyltestosterone polylactic acid by HPLC. Methods: Diamonsil-C₁₈(250 mm×4.6 mm,5 μm) column was used with the mobile phase consisting of methanol-water (72∶28).The ultraviolet detector was set at 241 nm,the flow rate was 1.0 mL·min^-1and the injection volume was 10 μL.The column temperature was 30 ℃. Results: The standard curve of methyltestosterone was linear in the concentration range of 10-115 μg·mL^-1 (r=0.9999).The average recovery was 99.5%(n=9).Conclusions: The method is simple,sensitive and applicable for the quality control of methyltestosterone in microspheres of methyltestosterone polylactic acid.

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