HPLC测定二氟泼尼酯眼用乳剂的含量
王金虎;郭文建
【期刊名称】《食品与药品》 【年(卷),期】2012(014)006
【摘要】Objective To establish an HPLC method for the determination of the difluprednate in difluprednate ophthalmic emulsion. Methods SHIMADZU VP-ODS C18 column (150 mm×4.6 mm, 5μnm) was adopted, the methanol-water (52:48) was used as mobile phase, the detection wavelength was 240 nm, the flow rate was 1.0 mL/ min, and the column temperature was 40 ℃. Results The linear range of difluprednate was 2.034- 20.34 ng/mL, the average recovery rate was 98.80%. Conclusion The method was simple, accurate and reproducible, can be used for quality control of difluprednate ophthalmic emulsion.%建立高效液相色谱法测定二氟泼尼酯眼用乳剂中二氟泼尼酯的含量.方法 采用SHIMADZU VP-ODS C1s (150mm× 4.6 mm,5μm)色谱柱,流动相为甲醇-水(52∶48),检测波长240 nm,流速1.0 mL/min,柱温35℃.结果 二氟泼尼酯在2.034~20.34 μg/mL浓度范围内与峰面积有良好的线性关系,平均回收率98.80%.结论 此方法结果简便,准确,重复性好,可以用于二氟泼尼酯眼用乳剂的质量控制. 【总页数】3页(428-430)
【关键词】高效液相色谱法;二氟泼尼酯;含量测定 【作者】王金虎;郭文建
【作者单位】山东省医药工业研究所,山东济南250101;山东省化药重点室验室,