Determination of related substances in hydrocortisone butyrate cream by HPLC
Objective:To establish a method for determining the content of related substances in hydrocortisone butyrate creamand to study the degradation kinetics and main degradation products of hydrocortisone butyrate at different pH values.Methods:Reverse-phase high-performance liquid chromatography(RP-HPLC)was performed on a Phenomenex Luna C18 column(250 mm×4.6 mm,5 μm)with a mobile phase consisting of water-acetonitrile-glacial acetic acid(55∶45∶5)at a flow rate of 1.0 ml/min.The column temperature was set at 30 ℃,and the detection wavelength was set at 240 nm.The injection volume was 20 μl.ResultsThe main components and impurities could be completely separated under the chromatographic conditions,and the linear range of detection mass concentration of hydrocortisone butyrate was 0.10～2.95 μg/ml(r=1.000 0).The average recovery was 100.3％and the RSD was 1.1％(n=6).The limits of quantification and detection were 2.0 ng and 1.0 ng,respectively.Hydrocortisone butyrate was relatively stable for 24 h.Conclusion:The established method is simple,sensitive,and can be used for the determination of related substances in hydrocortisone butyrate cream.
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