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Experimental research for determination of bisoprolol fumarate in human plasma samples using liquid chromatography- tandem mass spectrometry (LC-MS/MS) technique

机译:液相色谱-串联质谱(LC-MS / MS)技术测定人血浆样品中富马酸比索洛尔的实验研究

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Liquid chromatography coupled with mass spectrometry detection is one of the most powerful analytical tools for organic compound analysis. The advantages of using LC/MS methods over HPLC methods include: selectivity, chromatographic integrity, peak assignment, structural information, rapid method development. In this context, a liquid chromatography-tandem mass spectrometry method has been developed and validated for the determination of bisoprolol in human plasma samples, using metoprolol as internal standard. The assay has proven to be sensitive, specific and reproducible, suitable to determine the bisoprolol concentration, following a single oral administration of a 10 mg bisoprolol tablet in 22 healthy volunteers,.in the bioequivalence study of Bisoprolol 10 mg coated tablets, produced by Antibiotice S.A. versus Concor? 10 mg, produced by Merck.
机译:液相色谱结合质谱检测是有机化合物分析中最强大的分析工具之一。与HPLC方法相比,使用LC / MS方法的优势包括:选择性,色谱完整性,峰归属,结构信息,快速的方法开发。在这种情况下,已开发出一种液相色谱-串联质谱法,并已验证了使用美托洛尔作为内标测定人血浆样品中比索洛尔的方法。在抗生素生产的Bisoprolol包衣片剂10 mg的生物等效性研究中,已证明该测定法灵敏,特异性和可重复性,适合于在22位健康志愿者中单次口服10 mg bisoprolol片剂后确定比索洛尔浓度。 SA与Concor? 10毫克,由默克公司生产。

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