Validation of routine analytical method for injectable cyclosporine preparation control using HPLC-FIA assay
Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved..
OBJECTIVE: The aim of this study is to validate a new HPLC-FIA method for routine analytical control of cyclosporine injectable preparations and to evaluate the routine analytical control with this technic.
MATERIAL AND METHODS: Cyclosporine dosage was carried out by the HPLC-FIA method. The column was replaced by a PEEK (polyetheretherketone) loop tubing. The mobile phase consisted of ultrapure water. The injection volume was 1μL with a flow rate of 1mL/min. All determinations were performed at 35°C. The detection was carried out at 210nm. The accuracy profile method was used to validate the HPLC-FIA assay of cyclosporine. Routine control was applied for each cyclosporine preparation using the HPLC-FIA developed method. An acceptance limit of ±10% of the theoretical concentration has been set for the conformity of the preparation.
RESULTS: The accuracy profile shows the validity of our method for the dosage of cyclosporine in the concentration range studied (0.5-2.5mg/mL) with good linearity (correlation coefficient>0.999), high precision (the relative standard deviation [RSD] values, for both repeatability and intermediate precision, were<3%) and acceptable trueness (the relative biases were found<2%). In our study, 220 injectable cyclosporine preparations were analyzed: 85% were compliant. All analyzes were conform after a second standardized homogenization of 10 shakes.
CONCLUSIONS: The proposed HPLC-FIA method is a reliable, fast, simple, precise method that can be easily used for the routine quality control of cyclosporine injectable preparations.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:79 |
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| Enthalten in: |
Annales pharmaceutiques francaises - 79(2021), 3 vom: 01. Mai, Seite 266-274 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Drira, C [VerfasserIn] |
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| Links: |
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| Themen: |
83HN0GTJ6D |
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| Anmerkungen: |
Date Completed 25.10.2021 Date Revised 25.10.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.pharma.2020.10.006 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM316603082 |
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| 500 | |a Date Revised 25.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved. | ||
| 520 | |a OBJECTIVE: The aim of this study is to validate a new HPLC-FIA method for routine analytical control of cyclosporine injectable preparations and to evaluate the routine analytical control with this technic | ||
| 520 | |a MATERIAL AND METHODS: Cyclosporine dosage was carried out by the HPLC-FIA method. The column was replaced by a PEEK (polyetheretherketone) loop tubing. The mobile phase consisted of ultrapure water. The injection volume was 1μL with a flow rate of 1mL/min. All determinations were performed at 35°C. The detection was carried out at 210nm. The accuracy profile method was used to validate the HPLC-FIA assay of cyclosporine. Routine control was applied for each cyclosporine preparation using the HPLC-FIA developed method. An acceptance limit of ±10% of the theoretical concentration has been set for the conformity of the preparation | ||
| 520 | |a RESULTS: The accuracy profile shows the validity of our method for the dosage of cyclosporine in the concentration range studied (0.5-2.5mg/mL) with good linearity (correlation coefficient>0.999), high precision (the relative standard deviation [RSD] values, for both repeatability and intermediate precision, were<3%) and acceptable trueness (the relative biases were found<2%). In our study, 220 injectable cyclosporine preparations were analyzed: 85% were compliant. All analyzes were conform after a second standardized homogenization of 10 shakes | ||
| 520 | |a CONCLUSIONS: The proposed HPLC-FIA method is a reliable, fast, simple, precise method that can be easily used for the routine quality control of cyclosporine injectable preparations | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Accuracy profile | |
| 650 | 4 | |a Ciclosporine | |
| 650 | 4 | |a Control | |
| 650 | 4 | |a Contrôle | |
| 650 | 4 | |a Cyclosporine | |
| 650 | 4 | |a FIA | |
| 650 | 4 | |a Profil d’exactitude | |
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| 650 | 7 | |a 83HN0GTJ6D |2 NLM | |
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| 700 | 1 | |a Soussi, M A |e verfasserin |4 aut | |
| 700 | 1 | |a Razgallah Khrouf, M |e verfasserin |4 aut | |
| 700 | 1 | |a Fradi, I |e verfasserin |4 aut | |
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