RP-HPLC法同时测定复方酮康唑乳膏中二组分的含量及有关物质检查

目的采用反相高效液相色谱法测定酮康唑乳膏中酮康唑和丙酸氯倍他索的含量及有关物质。方法色谱柱为Diamonsil C18柱(250mm×4.6mm,5μm);流动相为甲醇-水(74∶26);检测波长为239nm;柱温为35℃。结果酮康唑、丙酸氯倍他索和有关物质能获得基线分离。酮康唑在0.16~1.44g·L-1,丙酸氯倍他索在4·0~36mg·L-1范围内峰面积与质量浓度呈良好的线性关系,相关系数分别为0.9999和0.9995(n=5),平均回收率分别为101.4%和101.5%,RSD分别为0.7%和1.4%(n=9)。结论本法快速,准确,专属性好,可用于酮康唑乳膏中酮康唑和丙酸氯倍他索的含量测定及有关物质检查。

Simultaneous assay and determination of related substances of ketoconazole and clobetasol propionate in the Compound Ketoconazole Cream by RP-HPLC

Objective To establish an RP-HPLC method for the determination of ketoconazole and clobetasol propionate and related substances in the Compound Ketoconazole Cream.Methods Chromatographic analysis was performed on Diamonsil C_ 18 column (250 mm×4.6 mm, 5 μm) with methanol-water (74∶26) as mobile phase. The flow rate was 1.0 mL·min~ -1 with the detection wavelength at 239 nm and column temperature at 35℃.Results Ketoconazole had a good linearity (r=0.999 9) in the range of 0.16~1.44 g·L~ -1 ,the mean recovery was 101.4%,and RSD= 0.7% .Clobetasol Propionate had a good linearity (r=0.999 5) in the range of 4~36 mg·L~ -1 ,the mean recovery was 101.5%,and RSD=1.4%. Conclusion The above method was simple, accurate and suitable for the determination of ketoconazole and clobetasol propionate and related substances in the Compound Ketoconazole Cream.