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Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high d...

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Autores principales: Stawny, Maciej, Gostyńska, Aleksandra, Dettlaff, Katarzyna, Jelińska, Anna, Kościelniak, Marta, Ogrodowczyk, Magdalena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963881/
https://www.ncbi.nlm.nih.gov/pubmed/31847501
http://dx.doi.org/10.3390/antibiotics8040268
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author Stawny, Maciej
Gostyńska, Aleksandra
Dettlaff, Katarzyna
Jelińska, Anna
Kościelniak, Marta
Ogrodowczyk, Magdalena
author_facet Stawny, Maciej
Gostyńska, Aleksandra
Dettlaff, Katarzyna
Jelińska, Anna
Kościelniak, Marta
Ogrodowczyk, Magdalena
author_sort Stawny, Maciej
collection PubMed
description Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated. Methods: An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 µm) with a C18 pre-column (LiChrospher 100, 4 mm, 5 µm). The flow rate was 1.0 mL min(−1) and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up. Results: The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures. Conclusions: The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t(0.5) varied from 142.44 h to 300.45 h).
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spelling pubmed-69638812020-01-27 Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures Stawny, Maciej Gostyńska, Aleksandra Dettlaff, Katarzyna Jelińska, Anna Kościelniak, Marta Ogrodowczyk, Magdalena Antibiotics (Basel) Article Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated. Methods: An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 µm) with a C18 pre-column (LiChrospher 100, 4 mm, 5 µm). The flow rate was 1.0 mL min(−1) and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up. Results: The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures. Conclusions: The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t(0.5) varied from 142.44 h to 300.45 h). MDPI 2019-12-15 /pmc/articles/PMC6963881/ /pubmed/31847501 http://dx.doi.org/10.3390/antibiotics8040268 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Stawny, Maciej
Gostyńska, Aleksandra
Dettlaff, Katarzyna
Jelińska, Anna
Kościelniak, Marta
Ogrodowczyk, Magdalena
Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title_full Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title_fullStr Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title_full_unstemmed Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title_short Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures
title_sort development, validation, and stability assessment application of rp-hplc-dad method for quantification of ampicillin in total parenteral nutrition admixtures
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6963881/
https://www.ncbi.nlm.nih.gov/pubmed/31847501
http://dx.doi.org/10.3390/antibiotics8040268
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