论文部分内容阅读
目的::建立同时测定复方酮康唑凝胶中酮康唑、硝酸咪康唑含量的方法。方法:采用HPLC法,色谱柱为Hypersil BDS C18(416 mm ×200 mm,5μm);以0.5%醋酸铵溶液-0.2%三乙胺的甲醇溶液(20∶80)为流动相;流速为1.0 ml·min-1;检测波长为230nm,柱温:30℃,进样量20μl。结果:酮康唑在5.1~510.0 mg·L-1浓度范围内有良好的线性关系,r=0.9999。平均回收率为100.3%(RSD=0.38%,n=6)。硝酸咪康唑在5.0~500.0 mg·L-1浓度范围内有良好的线性关系,r=0.9999,平均回收率=99.9%(RSD=0.79%,n=6)。结论:该方法能简便、快速、准确、灵敏地同时测定酮康唑、硝酸咪康唑的含量,可以用于复方酮康唑凝胶的质量控制。“,”Objective: To establish a method for the determination of ketoconazole and miconazole nitrate in compound ketocon-azole gels. Methods:An HPLC method was developed. A Hypersil BDS C18 column(416 mm × 200 mm,5μm) was used, the mobile phases consisted of 0. 5% ammonium acetate solution-methanol(containing 0. 2% triethanolamine) (20∶80), the flow rate was 1. 0 ml ·min-1 , the detection wavelength was set at 230nm, the column temperature was 30℃ and the injection volume was 20μl. Results:There was a good linear correlation within the range of 5. 1-510. 0 mg·L-1 for ketoconazole (r=0. 999 9) and 50. 0-500. 0 mg·L-1 for miconazole nitrate (r=0. 999 9), the average recovery for ketoconazole and miconazole nitrate was 100. 3%(RSD=0. 38%, n=6) and 99. 9%(RSD=0. 79%, n=6), respectively. Conclusion:The method is simple, rapid, accurate and sensitive, and can pro-vide a method for controlling the quality of compound ketoconazole gels.