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洛索洛芬钠含量测定方法学研究OA

Study on Methodology for Determination of Contents of Loxoprofen Sodium

中文摘要英文摘要

目的 建立液相色谱法测定洛索洛芬钠含量的方法并对其进行方法学研究.方法 采用液相色谱法,以甲醇-水-冰醋酸-三乙胺(600∶400∶1∶1)为流动相,等度洗脱,柱温为 35℃,流速为1.0 ml/min,检测波长222 nm.结果 洛索洛芬钠浓度在 30~78 μg/ml范围内线性关系良好(r=0.999 99),重复性、中间精密度、准确性及耐用性均满足要求,检测限为0.012 μg/ml,定量限为0.048 μg/ml.结论 该方法适用性较强,耐用性好,灵敏度高,可用于洛索洛芬钠原料药含量测定,洛索洛芬钠片及胶囊溶出度、含量均匀度及含量测定等项目分析.

Objective To establish a liquid chromatography method for the determination of loxoprofen sodium content and conduct methodological research on it.Methods Liquid chromatography was used,with methanol water glacial acetic acid triethylamine(600∶400∶1∶1)as the mobile phase,with equal elution.The column temperature was 35℃,the flow rate was 1.0 ml/min,and the detection wavelength was 222 nm.Results The concentration of loxoprofen sodium was linear when its concentrate range was from 30 to 78 μg/ml(r=0.999 99).The repeatability,intermediate precision,accuracy,and durability are meet the requirements.The detection limit is 0.012 μg/ml,and the quantitative limit is 0.048 μg/ml.Conclusion This method has strong applicability,good durability,and high sensitivity,and can be used for the determination of the content of loxoprofen sodium raw materials,dissolution,content uniformity,and content determination of loxoprofen sodium tablets and capsules.

蒋晓勤;陈雨蕉;付金凤

常州市食品药品纤维质量监督检验中心,江苏常州 213000

药学

洛索洛芬钠含量测定方法学

Loxoprofen sodiumDetermination of contentsMethodology

《中国药物经济学》 2024 (001)

97-101,107 / 6

国家药品监督管理局2023年国家药品抽验计划(序号7)

10.12010/j.issn.1673-5846.2024.01.020

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