摘要
目的建立酮洛芬凝胶中药物含量测定的方法,并明确光照对含量测定的影响。方法采用Diamonsil ODS柱（4.6 mm×200 mm,5μm）;流动相为0.01 mol/L磷酸二氢钾溶液（用磷酸调pH值至3.0）-乙腈（50∶50）,流速1.0 mL/min,检测波长为255 nm,柱温为室温。结果在本试验条件下,酮洛芬凝胶中与辅料及有关物质分离度均符合要求,酮洛芬进样量在0.525-1.575μg范围内线性关系良好（r=0.999 9,n=5）,平均回收率为98.41%,RSD为1.35%（n=3）。经光照,酮洛芬含量明显降低,杂质A明显增加,杂质A为酮洛芬的光照降解产物。结论本方法简单、快捷,可用于酮洛芬凝胶中药物含量的测定。
Objective To establish a RP-HPLC method for the determination of ketoprofen in ketoprofen gel.Methods The separation was performed with a Diamonsil C18column（4. 6 mm × 200 mm,5 μm） at room temperature,with the mobile phase of 0. 01 mol /L potassium phosphate（adjust with phosphoric acid to pH value of 3. 0）-acetonitrile（50∶ 50）. The flow rate was 1 mL /min. Ketoprofen was detected at 255 nm. Results There was a good linear relationship between A and concentration over the range of 0. 525 -1. 575 μg（r = 0. 999 9,n = 5）. The average recovery was 98. 41%,RSD was 1. 35%. After light irradiation,the content of ketoprofen decreased obviously and the impurity A ketoprofen increased significantly. Conclusion This method is applicable for the determination of ketoprofen in ketoprofen gel.
出处
《实用药物与临床》
CAS
2014年第10期1302-1305,共4页
Practical Pharmacy and Clinical Remedies
