Bioanalytical tandem mass spectrometry method for cinacalcet in human plasma: green assessment with advanced metrics.

IF 1.8 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2025-07-01 Epub Date: 2025-07-29 DOI:10.1080/17576180.2025.2535945

Anil Kollapareddy, Kousrali Sayyad, Leela Prasad Kowtharapu, Naresh Konduru, Tanmoy Mondal, Mohan Varkolu, Sreedhar Gundekari

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引用次数: 0

Abstract

Aims: This study aims to address the clinical need for managing secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on dialysis and hypercalcemia in individuals with parathyroid carcinoma or primary hyperparathyroidism (PHPT) ineligible for parathyroidectomy. Cinacalcet, a key calcimimetic agent, targets the calcium-sensing receptor (CaSR) in the parathyroid gland to lower elevated parathyroid hormone (PTH) levels. The study focuses on developing a robust high-performance liquid chromatography tandem mass spectrometry method for cinacalcet quantification to support therapeutic monitoring and pharmacokinetics.

Methods: A bioanalytical method using cinacalcet-D3 (CCT-D3) as an internal standard and tandem mass spectrometry in positive ion mode for accurate quantification employing Triple Quad Mass spectrometer in normal mode and a Zorbax Eclipse XDB-C18 column.

Results: The method was comprehensively validated, demonstrating reliability through high precision, accuracy, linearity within the range of 0.300-150.00 ng/mL, and stability, all in compliance with established bioanalytical guidelines. Furthermore, its environmental sustainability was assessed using modern green chemistry evaluation metrics.

Conclusion: This study presents a robust, selective LC-MS/MS assay for quantifying cinacalcet in human plasma. The assay demonstrates excellent linearity, precision, and recovery, making it suitable for pharmacokinetic studies, therapeutic drug monitoring, and bioequivalence or bioavailability assessments.

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人血浆中甲沙星的生物分析串联质谱法：先进指标的绿色评价。

目的：本研究旨在解决慢性肾脏疾病（CKD）透析和高钙血症患者的继发性甲状旁腺功能亢进（SHPT）的临床需要，这些患者患有甲状旁腺癌或原发性甲状旁腺功能亢进（PHPT），不适合进行甲状旁腺切除术。Cinacalcet是一种关键的拟钙化剂，靶向甲状旁腺中的钙感应受体（CaSR），以降低甲状旁腺激素（PTH）水平升高。该研究的重点是开发一种强大的高效液相色谱串联质谱法用于cinacalcet定量，以支持治疗监测和药代动力学。方法：以cinacalcet-D3 （CCT-D3）为内标，采用正离子模式串联质谱法，常规模式三重四元质谱仪和Zorbax Eclipse XDB-C18色谱柱进行精确定量。结果：方法经全面验证，精密度高，准确度高，线性范围在0.300 ~ 150.00 ng/mL，稳定性好，符合生物分析指南。采用现代绿色化学评价指标对其环境可持续性进行了评价。结论：本研究提供了一种可靠的、选择性的LC-MS/MS定量人血浆中甲钙素的方法。该方法具有良好的线性、精密度和回收率，适用于药代动力学研究、治疗药物监测、生物等效性或生物利用度评估。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.