HPLC梯度洗脱法检查甲睾酮喷雾剂中的有关物质

Determination of related substances in Methyltestosterone spray by HPLC gradient elution

目的建立检查甲睾酮喷雾剂中有关物质的方法。方法采用HPLC梯度洗脱法,色谱柱为VP-C18柱(250 mm×4.6 mm,5μm);以甲醇-乙腈-水(33:22:45)为流动相A,乙腈为流动相B,梯度洗脱;检测波长241 nm;柱温35℃;流速1.0 m l.m in-1。结果在选定的色谱条件下,主成分与有关物质能完全分离,各杂质峰分离良好,最低检测限为0.06 ng。结论所建方法专属性强、灵敏度高、重复性好,可用于检查甲睾酮喷雾剂的有关物质。

OBJECTIVE To establish a method for the determination of related substances in Methyltestosterone Spray.METHODS HPLC gradient elution was adopted.The separation was performed on a Shiseido VP-ODS column（250 mm×4.6 mm,5 μm）with the mobile phases of A[methanol-acetonitrile-water（33：22：45）] and B[acetonitrile] by gradient elution.The detection wave-length was set at 241 nm.The column was maintained at 35℃ and the flow rate was 1.0 ml·min^-1.RESULTS Related substances were completely separated from the main constituent and the impurities can separated well from each other.The limit of determination was 0.06 ng.CONCLUSION The method is selective,sensitive,accurate and suitable for the determination of related substances in Methyltestosterone spray.