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布洛芬混悬液有关物质检验方法研究

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目的 建立高效液相色谱法(HPLC)测定布洛芬混悬液中的有关物质.方法 采用Spherisorb ODS2(4.6 mm×150 mm,5 μm)为色谱柱,磷酸-四氢呋喃-乙腈-水(0.5:10:340:650)为流动相,流速2.0 ml/min,检测波长:214 nm,柱温:30℃,进样量:20 μl.结果 布洛芬及各杂质峰间分离良好,各杂质在相应浓度范围内线性关系良好,线性相关系数均大于0.999,平均回收率在98%~102%范围内.结论 此法操作简便、快捷、准确,专属性好,适用于布洛芬混悬液中的有关物质测定,有利于质量控制.
Detection of Related Substances in Ibuprofen Oral Suspension
Objective To establish an HPLC method for the determination of related substances in Ibuprofen Oral Suspension.Methods An Spherisorb ODS2 column(4.6 mm×150 mm,5 μm)was used,with phosphoric acid-tetrahydrofuran-acetonitrile-water(0.5:10:340:650)as the mobile phase.The flow rate was 2.0 ml/min,the detection wavelength was 214 nm and the column temperature was 30℃.The injection volume was 20 μl.Results Ibuprofen and its impurities were well separated.The linear correlation coefficients were all greater than 0.999.The average recoveries were in the range of 98%-102%.Conclusion The method is simple,rapid,accurate,and is suitable for the determination of related substances in Ibuprofen Oral Suspension,which is conductive to quality control.

Ibuprofen Oral Suspensionrelated substancetesting methodHPLC

张上上、王艳博、王英、王学涛、倪阳

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秦皇岛市食品药品检验中心,河北 秦皇岛 066000

布洛芬混悬液 有关物质 检验方法 高效液相色谱

河北省药品监督管理局科技计划项目

2023ZC1032

2024

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子:0.537
ISSN:1672-979X
年,卷(期):2024.26(5)
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