Development and validation of a HPLC method for quantifica-tion of degradation impurities of salbutamol sulfate with following long-term stability studies in multicomponent cough syrup.
Ceska Slov Farm
; 69(5-6): 211-217, 2020.
Article
en En
| MEDLINE
| ID: mdl-33736446
ABSTRACT
Medicines containing both a herbal extract and a synthetic substance are in high demand due to their beneficial effects and synergism. The novel combination of salbutamol sulfate and Hedera helix extracts seems to be prospective in terms of pharmacological activity. But for quality assurance, impurities of the synthetic component have to be determined and quantified. Plant extracts consist of various phytochemical components, therefore, it is more complicated to develop a selective analytical method due to the sample matrix. To prove the safety and efficacy of the dosage form, a new HPLC method for analysis of salbutamol sulfate impurities was developed and validated. The method was used to estimate the safety of the novel syrup by performing long-term stability studies for 24 months. Obtained results indicated the absence in both significant reducing of the main components content and increasing of related substances level. Also, force degradation was carried out to prognosticate the possibility of impurities producing.
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Base de datos:
MEDLINE
Asunto principal:
Tos
/
Albuterol
Tipo de estudio:
Observational_studies
Idioma:
En
Revista:
Ceska Slov Farm
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
Año:
2020
Tipo del documento:
Article