论文部分内容阅读
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 study the HPLC method for the determination of amorolfine hydrochloride cream in vitro by pig skin permeation and storage. METHODS: In vitro penetration tests were performed using Bama Xiaoxiang pig in vitro pigskin and a modified Franz diffusion cell. Using 90% acetonitrile as the extraction solvent and ketoconazole as the internal standard, the column was Diamonsil-C18 column (150 mm × 4.6 mm, 5 μm) and the mobile phase was methanol-ammonium dihydrogen phosphate solution ) At 70:30, the flow rate was 1.0 m L · min-1, the detection wavelength was 214 nm and the column temperature was 30 ℃. Results: The linear range of amorolfine hydrochloride was 1.13 ~ 8.05μg · m L-1 and the average recoveries were (105.48 ± 2.58)%, (99.46 ± 1.79), )% And (101.41 ± 2.00)%, respectively, with good precision (RSD 1.36%). The limits of quantification and limit of detection were 6.73 and 2.71 ng · m L-1, respectively. Conclusion: The method is specific, accurate and reproducible. It can be applied to skin bioequivalence study of amorolfine hydrochloride cream.