Development of a high-performance liquid chromatography using rhodamine B hydrazide as the derivatization reagent for determination of β propiolactone residues in inactivated COVID-19 vaccines

IF 2.8 3区医学 Q2 BIOCHEMICAL RESEARCH METHODS

Journal of Chromatography B Pub Date : 2024-07-15 DOI:10.1016/j.jchromb.2024.124241

Seyedeh Zohreh Mirjalili , Fatemeh Chavoshi , Mohsen Amini , ZahraTamiji , Farzad Kobarfard , Mehrnoosh Shirangi

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引用次数: 0

Abstract

β-propiolactone (BPL) is an alkylating agent used for inactivation of biological samples such as vaccines. Due to its known carcinogenic properties, complete hydrolysis of BPL is essential, and the detection of trace amounts is crucial. In this study a novel High-Performance Liquid Chromatography-Ultraviolet (HPLC-UV) method was developed. Rhodamine B hydrazide (RBH) was synthesized and utilized as a derivatizing reagent to react with BPL. The reaction was optimized in a weak acidic solution, resulting in a high yield. The separation of the RBH-derivatized BPL was achieved on a C8 column and detected by a UV detector at a wavelength of 560 nm. The method's validation demonstrated a high linearity (r2 > 0.99) over a concentration range of 0.5–50 µg/mL, with detection and quantification limits of 0.17 µg/mL and 0.5 µg/mL, respectively. The average recovery of samples was 85.20 % with a relative standard deviation (RSD) of 1.75 %. This method was successfully applied for BPL residue analysis in inactivated COVID-19 vaccines. This novel derivatization method offers a promising solution for monitoring BPL residues in the vaccine production process for quality control purposes and compliance with regulatory standards.

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开发一种以罗丹明 B酰肼为衍生试剂的高效液相色谱法，用于测定 COVID-19 灭活疫苗中的β丙内酯残留量

β-丙内酯（BPL）是一种烷基化剂，用于灭活疫苗等生物样本。由于其已知的致癌特性，BPL 的完全水解至关重要，而痕量的检测也至关重要。本研究开发了一种新型高效液相色谱-紫外（HPLC-UV）方法。研究人员合成了罗丹明 B 酸肼 (RBH)，并将其作为衍生试剂与 BPL 发生反应。反应在弱酸性溶液中进行了优化，从而获得了高产率。RBH 衍生化的 BPL 经 C8 色谱柱分离后，用波长为 560 nm 的紫外检测器检测。该方法在 0.5-50 µg/mL 浓度范围内线性关系良好（r2 > 0.99），检出限和定量限分别为 0.17 µg/mL 和 0.5 µg/mL。样品的平均回收率为 85.20%，相对标准偏差（RSD）为 1.75%。该方法被成功应用于 COVID-19 灭活疫苗中的 BPL 残留分析。这种新型衍生化方法为监测疫苗生产过程中的 BPL 残留提供了一种很有前景的解决方案，可用于质量控制并符合监管标准。

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来源期刊

Journal of Chromatography B 医学-分析化学

CiteScore

5.60

自引率

3.30%

发文量

306

审稿时长

44 days

期刊介绍： The Journal of Chromatography B publishes papers on developments in separation science relevant to biology and biomedical research including both fundamental advances and applications. Analytical techniques which may be considered include the various facets of chromatography, electrophoresis and related methods, affinity and immunoaffinity-based methodologies, hyphenated and other multi-dimensional techniques, and microanalytical approaches. The journal also considers articles reporting developments in sample preparation, detection techniques including mass spectrometry, and data handling and analysis. Developments related to preparative separations for the isolation and purification of components of biological systems may be published, including chromatographic and electrophoretic methods, affinity separations, field flow fractionation and other preparative approaches. Applications to the analysis of biological systems and samples will be considered when the analytical science contains a significant element of novelty, e.g. a new approach to the separation of a compound, novel combination of analytical techniques, or significantly improved analytical performance.