摘要
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 method for determining the quantity of the fluconazole dissolution in the capsules by HPLC. Methods Phenomenex Luna C18 olumn （4.6 nm × 250 nm） was used. The pH7.0 phosphate buffer - methanol （55 ： 45 ） was used as the mobile phase. The detection wavelength was 261 nm. The external standard method was used to determine the fluconazole content. Results The linear range of the quantity of fluconazole dissolution was 0.05 - 0.5 mg/ml （r = 0. 9998）. The average recovery rate and RSD was 99.8% and 0. 17% , respectively. Conclusion The method is convenient to operate, has good accuracy and precision, so it can be used for the quality control of fluconazole.
出处
《今日药学》
CAS
2009年第3期26-28,共3页
Pharmacy Today
关键词
高效液相色谱法
氟康唑胶囊
溶出量测定
HPLC
fluconazole capsules
determination of the quantity of dissolution
