Abstract
Objectives:
The stability of metronidazole has been demonstrated for high concentration and short-term storage. Little is known about the stability of its dilutions in 0.9% sodium chloride at concentrations relevant for neonatal clinical practice. This study aimed to evaluate the stability of metronidazole solutions at concentrations of 0.1 and 0.6 mg/mL, stored at room temperature and under refrigeration for 24 and 48 hours in 0.9% sodium chloride.
Methods:
Metronidazole concentrations were measured using a high-performance liquid chromatography method with ultraviolet detection. Calibration curves were linear over the concentration range of 0.025 to 1.25 mg/mL. Stability was defined as retention of 90% to 110% of the initial concentration. Results were expressed as percent deviation from the initial (0 hour) concentration, where 0% corresponds to the initial value (100%).
Key findings:
At room temperature, mean relative accuracy ranged from 0.7 ± 1.8% to 5.5 ± 1.1%. Under refrigeration, it ranged from −5.5 ± 4.0% to 3.5 ± 1.8%. All samples remained within the pharmacopeial acceptance range (90%-110%) of the initial concentration, corresponding to deviations within ±10%.
Conclusions:
Metronidazole concentrations of 0.1 and 0.6 mg/mL remained within the predefined acceptance limits for up to 48 hours in 0.9% w/v sodium chloride at 6°C and 22°C, supporting safe short-term storage in neonatal practice.
Get full access to this article
View all access options for this article.
References
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
