JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2020, 69(5):211-217 | DOI: 10.36290/csf.2020.029

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

Ivan Bezruk1,*, Anna Materiienko1, Svitlana Gubar1, Vera Bunyatyan2,3, Sergiy M. Kovalenko2,4, Victoriya Georgiyants1, Liudas Ivanauskas5
1 National University of Pharmacy, Department of Pharmaceutical Chemistry, Kharkiv, Ukraine
2 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, Moscow, Russia
3 Federal State Budgetary Institution "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation, Moscow, Russia
4 V. N. Karazin Kharkiv National University, Kharkiv, Ukraine
5 Lithuanian University of Health Sciences, Kaunas, Lithuania

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.

Keywords: long-term stability study; salbutamol sulfate; impurities; multicomponent dosage form; cough syrup; HPLC

Received: July 29, 2020; Accepted: October 12, 2020; Published: May 1, 2020  Show citation

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Bezruk I, Materiienko A, Gubar S, Bunyatyan V, Kovalenko SM, Georgiyants V, Ivanauskas L. 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. Čes. slov. farm. 2020;69(5-6):211-217. doi: 10.36290/csf.2020.029.
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