GC法检测布洛芬注射液中杂质F  

Determination of impurity F in ibuprofen injection by gas chromatography

作　　者：程开生 杨祥 臧洪梅[2] 

机构地区：[1]杭州锐思医药科技有限公司,浙江杭州310052 [2]安徽医科大学药学院,安徽合肥230032

出　　处：《安徽医药》2014年第5期823-825,共3页Anhui Medical and Pharmaceutical Journal

基　　金：科技部中小企业创新基金课题(No 09C26223304082);杭州市种子基金课题(No 20090531K10)

摘　　要：目的建立气相色谱法测定布洛芬注射液中的杂质F。方法采用气相色谱法,色谱柱:DB-WAXetr毛细管柱(25 m×0.53 mm×2μm),载气为氦气,流速5.0 mL·min-1,检测器为火焰离子化检测器,检测器温度为250℃,进样温度为200℃。结果在选定的条件下布洛芬和杂质完全分离,杂质F的检测限为2.5 mg·L-1,检测方法的精密度、准确度、灵敏度均达到了预定的分析要求。结论建立的方法准确、灵敏,适用于检测布洛芬注射液中的杂质F。Objective To establish a GC method to determine the impurity F in ibuprofen and its preparations. Methods The GC method was performed on a ZB-WAXetr capillary column（25 m × 0. 53 mm × 2 μm） and FID detector. The carrier gas was He with flow rate at 5 ml / min. The injector temperature and the detector temperature were 200℃ and 250℃,respectively. Results Under the described chromatographic condition,The impurity F was completely separated from ibuprofen. The LOD of impurity F was 2. 5 mg· L-1. Conclusions The analytical method is simple,accurate and sensitive with good reproducibility. It can be used to determine impurity F in ibuprofen and its preparations.

关 键 词：气相色谱法 布洛芬 杂质 

分 类 号：R927.2[医药卫生—药学]