Evaluation of vinburnine in pharmaceuticals by smart spectrophotometric methods; full stability study
Published by Elsevier B.V..
Vinburnine (VNB) is a vinca alkaloid used as a vasodilator to enhance cerebral circulatory insufficiency. It is a cyclic amide containing drug which is expected to be sensitive to hydrolytic degradation. The degradation profile of VNB was studied in this work following ICH recommendations for stability study. The drug was sensitive only to degradation with NaOH with the formation of the carboxylic acid derivative, identified by IR and 1H NMR analyses as 2-((1S,12bS)-1-ethyl-1,2,3,4,6,7,12,12b-octahydroindolo[2,3-a] quinolizin-1-yl) acetic acid, (DEG). In this study five simple, smart and univariate stability indicating spectrophotometric methods were developed and validated for simultaneous determination of VNB and DEG for the first time. The developed methods include; Dual Wavelength Method (DWM), Dual Wavelength Resolution Method (DWRM), Factorized Absorbance Difference Method (FADM), Advanced Absorbance Subtraction Method (AASM), and Derivative Amplitude Factor Method (DAFM). These methods were capable of determination of VNB and DEG over the ranges of 1-30 and 3-50 µg/mL, respectively. The proposed methods were simple, smart, specific, and could be applied for analyzing synthetic mixtures of VNB and DEG and were successfully applied for determination of the drug in commercially available capsules. The obtained results of these methods were statistically compared with the reported HPLC one using student's-t and F- tests, where no significant difference was observed. Validation of the developed methods was applied according to ICH recommendations and all the results were within the acceptable limits.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:249 |
|---|---|
| Enthalten in: |
Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy - 249(2021) vom: 15. März, Seite 119209 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Abdelwhab, Nada S [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 14.05.2021 Date Revised 14.05.2021 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.saa.2020.119209 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM318011913 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM318011913 | ||
| 003 | DE-627 | ||
| 005 | 20231225164451.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.saa.2020.119209 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1060.xml |
| 035 | |a (DE-627)NLM318011913 | ||
| 035 | |a (NLM)33234476 | ||
| 035 | |a (PII)S1386-1425(20)31188-4 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Abdelwhab, Nada S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of vinburnine in pharmaceuticals by smart spectrophotometric methods; full stability study |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 14.05.2021 | ||
| 500 | |a Date Revised 14.05.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published by Elsevier B.V. | ||
| 520 | |a Vinburnine (VNB) is a vinca alkaloid used as a vasodilator to enhance cerebral circulatory insufficiency. It is a cyclic amide containing drug which is expected to be sensitive to hydrolytic degradation. The degradation profile of VNB was studied in this work following ICH recommendations for stability study. The drug was sensitive only to degradation with NaOH with the formation of the carboxylic acid derivative, identified by IR and 1H NMR analyses as 2-((1S,12bS)-1-ethyl-1,2,3,4,6,7,12,12b-octahydroindolo[2,3-a] quinolizin-1-yl) acetic acid, (DEG). In this study five simple, smart and univariate stability indicating spectrophotometric methods were developed and validated for simultaneous determination of VNB and DEG for the first time. The developed methods include; Dual Wavelength Method (DWM), Dual Wavelength Resolution Method (DWRM), Factorized Absorbance Difference Method (FADM), Advanced Absorbance Subtraction Method (AASM), and Derivative Amplitude Factor Method (DAFM). These methods were capable of determination of VNB and DEG over the ranges of 1-30 and 3-50 µg/mL, respectively. The proposed methods were simple, smart, specific, and could be applied for analyzing synthetic mixtures of VNB and DEG and were successfully applied for determination of the drug in commercially available capsules. The obtained results of these methods were statistically compared with the reported HPLC one using student's-t and F- tests, where no significant difference was observed. Validation of the developed methods was applied according to ICH recommendations and all the results were within the acceptable limits | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Advanced absorbance subtraction | |
| 650 | 4 | |a Degradation profile | |
| 650 | 4 | |a Derivative amplitude factor | |
| 650 | 4 | |a Dual wavelength resolution | |
| 650 | 4 | |a Factorized absorbance difference | |
| 650 | 4 | |a Vinburnine | |
| 650 | 7 | |a Pharmaceutical Preparations |2 NLM | |
| 650 | 7 | |a Vinca Alkaloids |2 NLM | |
| 650 | 7 | |a eburnamonine |2 NLM | |
| 650 | 7 | |a NPD9S131ZU |2 NLM | |
| 700 | 1 | |a Emam, Aml A |e verfasserin |4 aut | |
| 700 | 1 | |a Habib, Neven M |e verfasserin |4 aut | |
| 700 | 1 | |a Mahmoud, Hamada M |e verfasserin |4 aut | |
| 700 | 1 | |a Abdelrahman, Maha M |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy |d 1998 |g 249(2021) vom: 15. März, Seite 119209 |w (DE-627)NLM090551192 |x 1873-3557 |7 nnns |
| 773 | 1 | 8 | |g volume:249 |g year:2021 |g day:15 |g month:03 |g pages:119209 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.saa.2020.119209 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 249 |j 2021 |b 15 |c 03 |h 119209 | ||