Vývoj a validace metody HPLC pro kvantifikaci nečistot degradace salbutamol-sulfátu s následujícími dlouhodobými stabilitními testy ve vícesložkovém sirupu proti kašli
Authors:
Ivan Bezruk 1; Anna Materiienko 1; Svitlana Gubar 1; Vera Bunyatyan 2,3; Sergiy M. Kovalenko 2,4; Victoriya Georgiyants 1; Liudas Ivanauskas 5
Authors‘ workplace:
National University of Pharmacy, Department of Pharmaceutical Chemistry
1; Federal State Autonomous Educational Institution of Higher Education I. M. Sechenov First Moscow State Medical University of the Ministry of Healthcare of the Russian Federation, 119991 Moscow, Russia
2; Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation, 127051 Moscow, Russia
3; V. N. Karazin Kharkiv National University, 61077 Kharkiv, Ukraine
4; Valentynivska Str. , 61100 Kharkiv, Ukraine
4; Lithuanian University of Health Sciences, 44307 Kaunas, Lithuania
5
Published in:
Čes. slov. Farm., 2020; 69, 211-217
Category:
Original article
Overview
Léky obsahující jak bylinný extrakt, tak syntetickou látku jsou velmi žádané kvůli jejich pozitivním účinkům a synergismu. Z hlediska farmakologické aktivity se nová kombinace salbutamol-sulfátu a extraktů Hedera helix jeví jako perspektivní. Pro zajištění kvality je však nutné určit a kvantifikovat nečistoty syntetické složky. Rostlinné extrakty se skládají z různých fytochemických složek, proto je složitější vyvinout selektivní analytickou metodu. Z důvodu prokázání bezpečnosti a účinnosti lékové formy byla vyvinuta a validována nová metoda HPLC pro analýzu nečistot salbutamol-sulfátu. Tato metoda byla použita k odhadu bezpečnosti nového sirupu provedením dlouhodobých stabilitních testů po dobu 24 měsíců. Získané výsledky naznačily absenci jak ve významném snížení obsahu hlavních složek, tak ve zvyšení hladiny látek příbuzných. Pro předpověď možnosti tvorby nečistot byla rovněž provedena tzv. síla degradace.
Klíčová slova:
dlouhodobé stabilitní testy – salbutamol-sulfát – nečistoty – vícesložková léková forma – sirup proti kašli – HPLC
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Pharmacy Clinical pharmacologyArticle was published in
Czech and Slovak Pharmacy
2020 Issue 5-6
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