Long-term stability of phenobarbital in various pharmaceutical products
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F22%3A10452235" target="_blank" >RIV/00216208:11310/22:10452235 - isvavai.cz</a>
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=xXyjotSF~q" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=xXyjotSF~q</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s00706-022-02950-8" target="_blank" >10.1007/s00706-022-02950-8</a>
Alternative languages
Result language
angličtina
Original language name
Long-term stability of phenobarbital in various pharmaceutical products
Original language description
Three historical phenobarbital-containing pharmaceutical preparations with an age of 36-57 years from the date of manufacture were analyzed. The analyzed preparations also differed in the type of dosage form: dragee, suppository, and solution. The aim was to evaluate the long-term stability of phenobarbital, within the systematic program aimed at studying the stability and degradation of active pharmaceutical ingredients in decades-old pharmaceutical products. The substances contained in the analyzed preparations were identified by reverse-phase HPLC with UV and high-resolution mass spectrometric detection, capillary zone electrolysis, and head-space solid-phase microextraction followed by GC-MS. The content of the main active ingredients was determined and compared with the values declared by the manufacturer. No degradation of phenobarbital was found in two preparations, dragée "Sedobelin" and suppository "Spasmoveralgin," so phenobarbital is stable in these preparations even after 36, respectively 43, years since the production of a preparation. In contrast, two degradation products were identified in the 57-year-old solution "Sklerophyllin": pheneturide and 3-aminopentanoic acid. The originally declared amount of phenobarbital was found to decrease by 12.5%. Thus, it is clear that phenobarbital is stable for many decades in solid dosage forms, whereas in liquid dosage forms it is partially degraded. In the second part of the work, ESI highresolution mass spectra of four selected substances were interpreted: phenobarbital, pheneturide, 3-aminopentanoic acid, and 3,4-methylenedioxymethamphetamine. The latter substance was surprisingly found in the suppository "Spasmoveralgin," probably as a degradation product of ephedrine contained in the product.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10406 - Analytical chemistry
Result continuities
Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Monatshefte für Chemie - Chemical Monthly
ISSN
0026-9247
e-ISSN
1434-4475
Volume of the periodical
153
Issue of the periodical within the volume
9
Country of publishing house
AT - AUSTRIA
Number of pages
10
Pages from-to
735-744
UT code for WoS article
000826839000001
EID of the result in the Scopus database
2-s2.0-85134499312