盐酸阿莫罗芬乳膏体外猪皮渗透贮留量的HPLC测定方法  

An HPLC method for the in vitro determination of retention of amorolfine hydrochloride cream via pig skin penetration

作　　者：孟凡敏[1,2] 贺吉香[1] 岳素荣[1,2] 孟鑫[2] 任寅 刘曲 顾兆姝 沈腾[2] 

机构地区：[1]山东中医药大学药学院,济南250355 [2]复旦大学药学院药剂学教研室,智能化递药教育部重点实验室,上海201203 [3]上海通用药业股份有限公司,上海201108

出　　处：《中国新药杂志》2016年第4期477-480,共4页Chinese Journal of New Drugs

摘　　要：目的：研究盐酸阿莫罗芬乳膏体外经猪皮渗透贮留量的HPLC测定方法。方法：采用巴马小香猪离体猪皮和改良的Franz扩散池进行体外渗透试验。采用90%乙腈作为提取溶剂,酮康唑作为内标,色谱柱为Diamonsil-C18柱（150 mm×4.6 mm,5μm）,流动相为甲醇-磷酸二氢铵溶液（磷酸调节p H值至3.0）（70∶30）,流速为1.0 m L·min-1,检测波长为214 nm,柱温为30℃。结果：盐酸阿莫罗芬的浓度在1.13~8.05μg·m L-1范围内与峰面积线性关系良好,低、中、高浓度平均回收率分别为（105.48±2.58）%,（99.46±1.79）%和（101.41±2.00）%,精密度良好（RSD为1.36%）。定量限和检测限浓度分别为6.73和2.71 ng·m L-1。结论：该方法专属性好、准确度高、重现性好,可应用于盐酸阿莫罗芬乳膏的皮肤生物等效性研究。Objective ： To establish an HPLC method for the in vitro determination of retention of amorolfine hydrochloride cream via pig skin penetration. Methods： The penetration experiments on in vitro pig skin were per- formed by modified Franz＇s cell using mama miniature pig skin. After being extracted with 90% acetonitrile solu- tion, samples were separated by HPLC method on a Diamonsil Cls column （150 mm ×4.6 mm,5 μm） with mobile phases of methanol-ammonium dihydrogen phosphate solution （70： 30, adjusted pH to 3.0 with phosphoric acid） and ketoconazole as an internal standard. The flow rate was 1.0 mL min-1 The detection wavelength was 214 nm. Results： Calibration curve for amorolfine hydrochloride was linear in the range of 1.13 - 8.05 μg mL-1 The average recoveries of low, medium and high concentrations were （ 105.48 ± 2.58）% , （99.46 ± 1.79）% and （101.41 ± 2.00）% , respectively. Precision was good （RSD = 1.36% ）. The limit of quantification and detection was 6.73 and 2.71 ng mL-1, respectively. Conclusion： The method has good specificity, high accuracy, and good reproducibility. Thus it can be used for the skin bioequibalence study related to amorolfine hydrochloride cream.

关 键 词：盐酸阿莫罗芬 高效液相色谱 内标 贮留量 猪皮 体外渗透试验 

分 类 号：R978.5[医药卫生—药品]