Hydrogen Peroxide Plasma Sterilization Sabotages the Efficacy of Lidocaine HCl Injection



Dini Aprilia1, Ririn Sumiyani2, Niniek Tripuspitasari3, Ade MWD Pambudi3, Christina Avanti4, *
1 Department of Clinical Pharmacy, Faculty of Pharmacy, University of Surabaya, Jalan Raya Kalirungkut, Surabaya, Indonesia
2 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Surabaya, Jalan Raya Kalirungkut, Surabaya, Indonesia
3 Center for Drug Evaluation and Analysis, Faculty of Pharmacy, University of Surabaya, Jalan Raya Kalirungkut, Surabaya, Indonesia
4 Department of Pharmaceutics, Faculty of Pharmacy, University of Surabaya, Jalan Raya Kalirungkut, Surabaya, Indonesia

Abstract

Background:

Lidocaine injection with 2% HCl as an anesthetic drug must guarantee its sterility to avoid microbial contamination. In efforts to maintain the sterile preparation of Lidocaine HCl 2% before use in hospitals, some anesthesiologists opt for re-sterilization.

Objective:

This study aimed to evaluate the impact of plasma sterilization using hydrogen peroxide on Lidocaine HCl levels employing a validated Ultra Performance Liquid Chromatography (UPLC) assay.

Methods:

The 2% Lidocaine HCl samples were separated into two groups, one undergoing re-sterilization with hydrogen peroxide and the other handled only with aseptic techniques. The chromatographic assay was performed using a Waters Corp Acquity UPLC® H-Class system and a Waters Corp Acquity UPLC® BEH C18 column, with a mobile phase of 20% Acetonitrile and 80% Acetate Buffer pH 3.4, flow rate of 0.3 mL/min, and total duration of 4.5 minutes.

Results:

The results showed a decrease in Lidocaine HCl levels to 1.88% after re-sterilization and 2.01% without re-sterilization.

Conclusion:

These findings suggest that re-sterilization with hydrogen peroxide plasma sterilization leads to a significant decrease in Lidocaine HCl levels, causing non-compliance with pharmacopoeia standards.

Keywords: Hydrogen peroxide, Plasma sterilization, Lidocaine HCl, Anesthetic drugs, Sterility, UPLC.


Abstract Information


Identifiers and Pagination:

Year: 2023
Volume: 17
DOI: 10.2174/25896458-v17-e230919-2023-8

Article History:

Electronic publication date: 19/09/2023
Collection year: 2023

© 2023 Aprilia et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


* Address correspondence to this author at the Department of Pharmaceutics, Faculty of Pharmacy, University of Surabaya, Jalan Raya Kalirungkut, Surabaya, Indonesia; Tel.: +62 31-298-1100; Fax: +62 31 298 1111; E-mail: c_avanti@staff.ubaya.ac.id