复方酮康唑发用洗剂中有关物质检测方法的研究

Determination of Related Substances of Ketoconazole in Compound Ketoconazole Lotion for Scalp Disorders

采用Agilent C18色谱柱;流动相A为0.034%四丁基硫酸氢铵溶液,流动相B为乙腈,俩相梯度洗脱;检测波长为220 nm;流速1.0 m L/min;柱温35℃,测定复方酮康唑发用洗剂中有关物质,有效的控制产品质量。结果表明,主峰与前后各杂质峰分离良好;重复性试验中总杂平均含量为0.52%,RSD为2.97%;稳定性试验中杂质个数无变化,最大单杂RSD为2.33%,总杂RSD为1.92%。本法准确,专属性好,重现性好,可用于复方酮康唑发用洗剂中有关物质的测定。

An HPLC method for the determination of related substances in the compound ketoconazole lotion for scalp disorders was established. Chromatographic analysis was performed on Agilent C18 column. Mobile phase A was 0. 034%solution of tetrabutylammonium hydrogen sulfate,mobile phase B was acetonitrile,two phase gradient elution. The detection wavelength was 220 nm,the flow rate was 1. 0 m L/min,and the column temperature was 35 ℃. The seperation of related substances was good. In repeatability test,the total impurity content was 0. 52%,RSD was 2. 97%. There was no change in the number of impurities in the stability test. RSD of the maximum single impurity was 2. 33%,and RSD of the total impurity was 1. 92%. The above method was simple,accurate and suitable for determination of related substance in the compound ketoconazole lotion for scalp disorders,and it can effectively control the quality of products.