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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 Publisher Pubmed



Zohreh Mirjalili S1 ; Chavoshi F1 ; Amini M2 ; Kobarfard F4 ; Shirangi M1, 5
Authors
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Authors Affiliations
  1. 1. Department of Drug and Food Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Medicinal Chemistry, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Chemometrics, The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Medicinal Chemistry, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5. PharmaBridge, Pharmaceutical Consultancy Company, Jule Stynestraat 102, Utrecht, 3543 DS, Netherlands

Source: Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences Published:2024


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. © 2024 Elsevier B.V.
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