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目的建立高效液相色谱(HPLC)法测定氟康唑胶囊中氟康唑的溶出量。方法采用Phenomenex Luna C18色谱柱(4.6nm×250nm),流动相为pH7.0的磷酸盐缓冲液——甲醇(55∶45),检测波长为261nm,采用外标法测定氟康唑胶囊的溶出量。结果溶出量在0.05～0.5mg/ml浓度范围内,线性良好(r=0.9998),平均回收率为99.8%,相对标准偏差值(RSD)=0.17%。结论本法操作简便,准确度高,精密度好,可有效控制产品的质量。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of fluconazole in fluconazole capsules. Methods Phenomenex Luna C18 column (4.6 nm × 250 nm) was used. The mobile phase was phosphate buffer-methanol (55:45) at pH 7.0. The detection wavelength was 261 nm. The dissolution of fluconazole capsules was determined by external standard method the amount. The results showed that the average recovery was 99.8% and the relative standard deviation (RSD) was 0.17%. The average dissolution was within the range of 0.05-0.5 mg / ml. Conclusion This method is simple, accurate, precise, and can effectively control the quality of the product.