A Rapid and Sensitive Method for the Determination of Bisoprolol in Human Plasma by Ultra Performance Liquid Chromatography–Tandem Mass Spectrometry

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2025-04-02 DOI:10.1002/bmc.70054

Yihong Jiang, Yaling Niu, Congchao Ning, Feng Qin, Chengda Yan, Xiumei Lu

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Abstract

A rapid and sensitive ultra-high performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS) method for the determination of bisoprolol in human plasma was established and validated. The sample was pretreated by methanol precipitation protein, and the isotope bisoprolol-d₅ was used as the internal standard. The chromatographic column was ACQUITY UPLC BEH-C₁₈ column (2.1 × 50 mm, 1.7 μm), with methanol and 0.2% formic acid aqueous solution as mobile phase for gradient elution. The electrospray ionization (ESI) source was used in the positive ion mode, and the multiple reaction monitoring (MRM) mode was used. The total running time was only 2.00 min. The correlation coefficient was good (r > 0.99) in the linear range of 0.0200–40.0 ng/mL. The lower limit of quantitation (LLOQ) was 20.0 pg/mL. The intrabatch and interbatch precisions were not more than 8.9% and 9.2%. The intrabatch and interbatch accuracies were −7.9% ~ 6.3% and −6.9% ~ 5.0%. The method was fully validated including whole blood stability and reinjection reproducibility and successfully applied to the pharmacokinetic study of 5-mg bisoprolol in healthy volunteers, which 93.1% incurred samples reanalysis (ISR) met the criteria. Compared with the reported methods, this method had the highest sensitivity and fast analysis speed.

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超高效液相色谱-串联质谱法测定人血浆中比索洛尔的快速灵敏方法

建立了快速灵敏的超高效液相色谱-串联质谱（UHPLC-MS/MS）测定人血浆中比索洛尔的方法，并进行了验证。样品采用甲醇沉淀蛋白预处理，以同位素异丙洛-d5为内标。色谱柱为ACQUITY UPLC BEH-C18柱（2.1 × 50 mm, 1.7 μm），以甲醇和0.2%甲酸水溶液为流动相，梯度洗脱。正离子模式采用电喷雾电离（ESI）源，多反应监测（MRM）模式。总运行时间仅为2.00分钟。在0.0200 ~ 40.0 ng/mL的线性范围内，相关系数良好（r > 0.99）。定量下限为20.0 pg/mL。批内精密度和批间精密度分别不超过8.9%和9.2%。批内和批间准确度分别为- 7.9% ~ 6.3%和- 6.9% ~ 5.0%。该方法经全血稳定性和再注射重复性验证，并成功应用于5 mg比索洛尔在健康志愿者体内的药代动力学研究，93.1%的样品再分析（ISR）符合标准。与已有报道的方法相比，该方法灵敏度最高，分析速度快。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.