1. 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.
- Author
-
Zohreh Mirjalili S, Chavoshi F, Amini M, ZahraTamiji, Kobarfard F, and Shirangi M
- Subjects
- Chromatography, High Pressure Liquid methods, Reproducibility of Results, Vaccines, Inactivated chemistry, Vaccines, Inactivated analysis, Linear Models, SARS-CoV-2 chemistry, Humans, Hydrazines chemistry, Hydrazines analysis, Propiolactone chemistry, Rhodamines chemistry, Limit of Detection, COVID-19 Vaccines chemistry
- 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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF