Hydrogen Peroxide Plasma Sterilization Sabotages the Efficacy of Lidocaine HCl Injection

Aprilia, Dini; Sumiyani, Ririn; Tripuspitasari, Niniek; Pambudi, Ade MWD; Avanti, Christina

Hydrogen Peroxide Plasma Sterilization Sabotages the Efficacy of Lidocaine HCl Injection

Dini Aprilia¹, Ririn Sumiyani², Niniek Tripuspitasari³, Ade MWD Pambudi³, Christina Avanti^{4, *}

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

Article Information

Identifiers and Pagination:

Year: 2023
Volume: 17
E-location ID: e258964582309130
Publisher ID: e258964582309130
DOI: 10.2174/0125896458247890230921045721

Article History:

Received Date: 06/02/2023
Revision Received Date: 24/07/2023
Acceptance Date: 16/08/2023
Electronic publication date: 30/10/2023
Collection year: 2023

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© 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

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.

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RESEARCH ARTICLE

Hydrogen Peroxide Plasma Sterilization Sabotages the Efficacy of Lidocaine HCl Injection

Article Information

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Abstract

Background:

Objective:

Methods:

Results:

Conclusion:

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