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Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions

BACKGROUND: The use of a combination of different drugs in postoperative analgesia extends the time of analgesia, makes it more efficient and allows the use of lower drug doses, which leads to less risk of side effects and drug dependence. The aim of this study was to develop and validate an HPLC me...

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Autores principales: Piekarski, Mikołaj, Jelin'ska, Anna, Szymczak, Kamil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Group 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591257/
https://www.ncbi.nlm.nih.gov/pubmed/23487596
http://dx.doi.org/10.1136/ejhpharm-2012-000088
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author Piekarski, Mikołaj
Jelin'ska, Anna
Szymczak, Kamil
author_facet Piekarski, Mikołaj
Jelin'ska, Anna
Szymczak, Kamil
author_sort Piekarski, Mikołaj
collection PubMed
description BACKGROUND: The use of a combination of different drugs in postoperative analgesia extends the time of analgesia, makes it more efficient and allows the use of lower drug doses, which leads to less risk of side effects and drug dependence. The aim of this study was to develop and validate an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in standard infusion solutions of 0.9% sodium chloride and 5% glucose. METHODS: After optimisation, the HPLC method parameters were as follows: LiChrospher 100 CN, 250×4 mm (10 µm) column; mobile phase: mixture of acetonitrile and phosphate buffer at pH 2.8 (3:7, V/V) with addition of 0.08 g/l potassium chloride; flow rate: 1.5 ml/min; column temperature: 30°C; spectrophotometric detection at 210 nm. Development of the method involved checking the impact of acetonitrile and KCl concentrations in the mobile phase and choosing the internal standard. Method validation included determining the specificity of the method, its accuracy, linearity, precision, repeatability, limits of detection and quantification. RESULTS: The retention times of bupivacaine hydrochloride, fentanyl citrate and procaine hydrochloride, used as an internal standard, were approximately 10 min, 15 min and 5 min, respectively. Method validation confirmed its selectivity, accuracy and precision. The average values of the variation and accuracy coefficients were 0.70% and 99.02% for bupivacaine hydrochloride, and 1.76% and 104.53% for fentanyl citrate. The intermediate precision values were 1.25% for bupivacaine hydrochloride and 1.52% for fentanyl citrate.
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spelling pubmed-35912572013-03-11 Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions Piekarski, Mikołaj Jelin'ska, Anna Szymczak, Kamil Eur J Hosp Pharm Sci Pract Research BACKGROUND: The use of a combination of different drugs in postoperative analgesia extends the time of analgesia, makes it more efficient and allows the use of lower drug doses, which leads to less risk of side effects and drug dependence. The aim of this study was to develop and validate an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in standard infusion solutions of 0.9% sodium chloride and 5% glucose. METHODS: After optimisation, the HPLC method parameters were as follows: LiChrospher 100 CN, 250×4 mm (10 µm) column; mobile phase: mixture of acetonitrile and phosphate buffer at pH 2.8 (3:7, V/V) with addition of 0.08 g/l potassium chloride; flow rate: 1.5 ml/min; column temperature: 30°C; spectrophotometric detection at 210 nm. Development of the method involved checking the impact of acetonitrile and KCl concentrations in the mobile phase and choosing the internal standard. Method validation included determining the specificity of the method, its accuracy, linearity, precision, repeatability, limits of detection and quantification. RESULTS: The retention times of bupivacaine hydrochloride, fentanyl citrate and procaine hydrochloride, used as an internal standard, were approximately 10 min, 15 min and 5 min, respectively. Method validation confirmed its selectivity, accuracy and precision. The average values of the variation and accuracy coefficients were 0.70% and 99.02% for bupivacaine hydrochloride, and 1.76% and 104.53% for fentanyl citrate. The intermediate precision values were 1.25% for bupivacaine hydrochloride and 1.52% for fentanyl citrate. BMJ Group 2012-10 /pmc/articles/PMC3591257/ /pubmed/23487596 http://dx.doi.org/10.1136/ejhpharm-2012-000088 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode
spellingShingle Research
Piekarski, Mikołaj
Jelin'ska, Anna
Szymczak, Kamil
Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title_full Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title_fullStr Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title_full_unstemmed Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title_short Development and validation of an HPLC method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
title_sort development and validation of an hplc method to determine the stability of fentanyl citrate and bupivacaine hydrochloride mixtures in infusion solutions
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591257/
https://www.ncbi.nlm.nih.gov/pubmed/23487596
http://dx.doi.org/10.1136/ejhpharm-2012-000088
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