| 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: |
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| 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-1；Detection 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. |
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