中文摘要：

建立高效液相色谱（HPLC）法测定酮康唑缓释微球的含量，为进一步研究微球中药物的缓释机理提供方法学基础。方法：利用微流控技术，制备乳酸一羟基乙酸共聚物载酮康唑药物微球。使用ODS C18（250min×4．6mm，5μm，迪马公司）色谱柱分离，流动相为甲醇／磷酸缓冲盐为80／20（磷酸缓冲盐：0．34mL磷酸与200mL双蒸馏水混合，用三乙胺调节pH=3．O），室温，流量为0．80mL／min，检测波长为242nm。结果：酮康唑在1．0～30．0μg／mL范围内线性关系好，r=0．9999。方法检出限为10．8ng／mL，回收率为100．28±0．38％，进样重现性RSD为0．07，精密度良好。结论：采用HPLC法测定缓释微球中酮康唑含量简便、快速、准确、线性范围宽、灵敏度高、精密度好，可用于微球中药物含量的测定及药物释放性能的研究。

英文摘要：

Objective to establish a HPLC method for the determination the contents of ketoconazole in sus- tained release microspheres and provide the methodological basis for the further study of the release mecha- nism. Prepare this ketoconazole microspheres coated by poly （lactide-co-glycolide） （PLGA） with mi- crofluidic technology. The ODS C18column （250 mmX4.6 mm, 5μm, Dikma Technologies ） was used at room temperature. The mobile phase consisted of methanol-phosphate buffer solution （80 ： 20） . The preparation of phosphate buffer solution is that 0. 34 mL phosphoric acid mixed with 200 mL double-dis- tilled water, and adjusted pH=3.0 with triethylamine. The flow rate was 0. 80 mL/min and the detective wavelength was 242 nm. Results： this linear ranges of ketoconazole was 1.0-30.0 ng/mL （r=0. 999 9） and the detection limit was 10.8 ng/mL. The recovery rate was 100.28±0. 38% （RSD=0.07, n=6）. Conclusion： this method is specific and accurate, and it can be used to monitoring the contents of ketocon-azole in the solution.