反相高效液相色谱法同时测定复方酮康唑搽剂中三组分的含量

目的: 建立反相高效液相色谱法同时测定复方酮康唑搽剂中酮康唑、苯甲酸和水杨酸的含量。 方法: 使用ZORBAX Eclipse XDB-C₁₈(4.6 mm×150 mm,5 μm),流动相为甲醇-乙睛-0.01 mol·L^-1磷酸二氢钾溶液(用磷酸调pH至2.0)(15:25:60),柱温30℃,流速为1.0 mL·min^-1,检测波长为220nm。 结果: 酮康唑、苯甲酸和水杨酸的线性范围分别为:4.128-20.64 μg·mL^-1(r=1.0000),12.156~60.780 μg·mL^-1(r=1.0000),6.032~30.160 μg·mL^-1(r=0.9998);平均回收率分别为98.7%、100.4%、100.1%;RSD分别为0.90%、0.56%、0.63%。 结论: 该方法快速、简便、灵敏,分离度好,其他成分无干扰,适用于控制产品质量。

Objective: To establish an RP-HPLC method for simultaneous determination of ketoconazole,benzoic acid and salicylic acid in compound ketoconazole liniment. Methods: The RP-HPLC was conducted on a ZORBAX Eclipse XDB-C₁₈ column(4.6 m m×150 mm,5 μm),with methanol-acetonitrile-0.01 mol·L^-1 KH₂PO₄ solution(15:25:60)(adjusted to pH 2.0 with phosphoric acid)as the mobile phase and the column temp erature was 30℃.The flow rate was 1.0 mL·min^-1 and the detection wavelength was 220 nm. Results: The linear ranges of ketoconazole,benzoic acid and salicylic acid were 4.128-20.64 μg·mL^-1(r=1.0000),12.156-60.780 μg·mL^-1(r=1.0000),6.032-30.160 μg·mL^-1(r=0.9998)respectively.The average recoveries were 98.7%(RSD=0.90%),100.4%(RSD=0.56%)and 100.1%(RSD=0.63%)respectively. Conclusion: The method is simple,sensitive,accurate and suitable to control product quality.

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