Historical analgesic tablets revisited: development of a versatile RP-HPLC method for the stability study of single- and multi-component pharmaceutical preparations

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F25%3A10504902" target="_blank" >RIV/00216208:11310/25:10504902 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=Hskhs4dNcS" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=Hskhs4dNcS</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1007/s00706-025-03350-4" target="_blank" >10.1007/s00706-025-03350-4</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Historical analgesic tablets revisited: development of a versatile RP-HPLC method for the stability study of single- and multi-component pharmaceutical preparations

Popis výsledku v původním jazyce

A versatile RP-HPLC method using phenyl-hexyl stationary phase and gradient elution (0.1% aqueous acetic acid and methanol) was developed to investigate the chemical integrity of twelve historical analgesic single- and multi-component preparations (1940s to 1990s). UV-Vis detection, supported by tandem mass spectrometry, was employed for compound identification and potential degradation product screening. Twelve active pharmaceutical ingredients (APIs) - including acetylsalicylic acid, bromisoval, caffeine, codeine, narcotine, phenacetine, phenobarbital, salicylic acid, and four distinct barbiturates - were investigated. Calibration models were established with limits of quantification as low as 3.0 mg dm(-3). Coelution of phenobarbital and aminophenazone was effectively resolved through mathematical correction using dual-wavelength detection. Most APIs demonstrated remarkable long-term stability (within +/- 10% of declared content), with the exception of codeine and acetylsalicylic acid in specific preparation. Effervescent and poorly stored tablets exhibited significant degradation, highlighting the importance of dosage form and storage conditions. In addition, the tandem mass spectrum of bromisoval is presented here for the first time in the literature, and a plausible fragmentation mechanism is proposed.

Název v anglickém jazyce

Historical analgesic tablets revisited: development of a versatile RP-HPLC method for the stability study of single- and multi-component pharmaceutical preparations

Popis výsledku anglicky

A versatile RP-HPLC method using phenyl-hexyl stationary phase and gradient elution (0.1% aqueous acetic acid and methanol) was developed to investigate the chemical integrity of twelve historical analgesic single- and multi-component preparations (1940s to 1990s). UV-Vis detection, supported by tandem mass spectrometry, was employed for compound identification and potential degradation product screening. Twelve active pharmaceutical ingredients (APIs) - including acetylsalicylic acid, bromisoval, caffeine, codeine, narcotine, phenacetine, phenobarbital, salicylic acid, and four distinct barbiturates - were investigated. Calibration models were established with limits of quantification as low as 3.0 mg dm(-3). Coelution of phenobarbital and aminophenazone was effectively resolved through mathematical correction using dual-wavelength detection. Most APIs demonstrated remarkable long-term stability (within +/- 10% of declared content), with the exception of codeine and acetylsalicylic acid in specific preparation. Effervescent and poorly stored tablets exhibited significant degradation, highlighting the importance of dosage form and storage conditions. In addition, the tandem mass spectrum of bromisoval is presented here for the first time in the literature, and a plausible fragmentation mechanism is proposed.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Monatshefte für Chemie - Chemical Monthly

ISSN

0026-9247

e-ISSN

1434-4475

Svazek periodika

156

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

AT - Rakouská republika

Počet stran výsledku

13

Strana od-do

1013-1025

Kód UT WoS článku

001543328600001

EID výsledku v databázi Scopus

2-s2.0-105012610330