文章摘要
蒋蒨,王平,李荣,李杰.HPLC法同时测定洛索洛芬钠片中的5个已知杂质[J].中国药品标准,2023,24(2):
HPLC法同时测定洛索洛芬钠片中的5个已知杂质
Development and validation of the related substances determination inLoxoprofen Sodium Tablets by HPLC
投稿时间:2022-06-28  修订日期:2023-03-29
DOI:
中文关键词: 洛索洛芬钠片  有关物质  校正因子  高效液相色谱法
英文关键词: loxoprofen sodium tablets  related substances  correction factor  HPLC
基金项目:
作者单位E-mail
蒋蒨* 重庆科瑞制药集团有限公司 jiangq97@126.com 
王平 重庆科瑞制药集团有限公司  
李荣 重庆科瑞制药集团有限公司  
李杰 重庆科瑞制药集团有限公司  
摘要点击次数: 339
全文下载次数: 724
中文摘要:
      目的: 建立同时测定洛索洛芬钠片中的5个已知杂质的有关物质HPLC法。方法:采用Intersil ODS-3(4.6×250 mm,5 μm);梯度洗脱,流动相为0.0 mol﹒L-1的磷酸二氢钾溶液(pH4.5)-乙腈(85:15)(A)和0.01mol﹒L-1的磷酸二氢钾溶液(pH4.5)-乙腈(15:85)(B),进行梯度洗脱,流速1.0mL.min-1检测波长220nm;柱温40℃;进样体积20μL。结果:该法专属性良好,洛索洛芬钠与相邻杂质以及5个已知杂质之间的分离均良好,洛索洛芬钠和5个已知杂质的浓度与峰面积之间线性关系均良好(r>0.9999);精密度、准确度和耐用性均良好;洛索洛芬钠片3批自制制剂与3 批参比制剂的杂质谱基本一致,各批样品均符合制订质量标准的规定。结论:该方法专属性强、灵敏度高、准确度和重复性好,可用于洛索洛芬钠片有关物质的控制。
英文摘要:
      [Objective]:An HPLC method was established for the simultaneous determination of five known impurities in loxoprofen sodium tablets. [Method]:Intersil ODS-3(4.6×250 mm,5 μm)was used;Mobile phase:0.01 mol﹒L-1potassium dihydrogen phosphate solution (pH4.5) - acetonitrile (85:15) (A) and 0.01 mol﹒L-1 potassium dihydrogen phosphate solution (pH4.5) - acetonitrile (15:85) (B),gradient elution;Flow rate:1.0mL.min-1Detection wavelength: 220nm;Column temperature:40℃; Injection volume:20μL。 [Result]:The established method had good specificity, satisfactory interference, and there was a good separation between Loxoprofen Sodium and adjacent impurity and known impurity. The linear relationship between concentration and corresponding peak area of Loxoprofen Sodium and all related substances were ideal (r > 0.9999). The precision, accuracy, and durability of this method were fine. The impurity spectra of 3 batches of self-made preparations and 3 batches of reference preparations of Loxoprofen Sodium Tablets were basically consistent, complying with the established quality standards.[Conclusion]:The method is specific,Sensitive,accurate and repeatable. It can be suitable for the determination of related substances in Loxoprofen Sodium Tablets.
  查看/发表评论  下载PDF阅读器
关闭