Abstract
Choline salicylate (CS) as a derivative of acetylsalicylic acid is commonly used in different drug forms. In medicine, it is applied topically to inflammation of the oral cavity mucosa and in laryngology. However, this substance in the form of an ionic liquid has not been investigated enough. There are no literature studies on stability tests constituting a stage of pre-formulation research. HPLC (Nucleosil C18, 4.6 × 150 mm, 5 μm; methanol-water-acetic acid 60:40:1, 230 nm or 270 nm) and UV (276 nm) methods for the determination of CS in 2% (g/mL) aqueous solutions were developed. Under stress conditions, CS susceptibility to hydrolytic degradation in aqueous medium, hydrochloric acid, sodium hydroxide, and hydrogen peroxide, and the effect of light on the stability of CS solutions were studied with HPLC analysis. The degradation degree of CS and the purity of the solutions were also tested. Choline salicylate has been qualified as practically stable in neutral and acid media, stable in an alkaline medium, very stable in an oxidizing environment, and photolabile in solution. The HPLC-MS/MS method was used to identify 2,3- and 2,5-dihydroxybenzoic acids as degradation products of CS under the tested conditions.
Highlights
Choline salicylate (CS) belongs to the group of non-steroidal anti-inflammatory drugs (NSAID)derived from salicylic acid
high performance liquid chromatography (HPLC)-MS/MS analysis did not confirm the presence of 2,3- and 2,5dihydroxybenzoic acids as well as pyrocatechol and phenol in CS solutions subjected to basic
CS solutions subjected to acid and base hydrolysis, after their neutralization, were analyzed with HPLC-MS/MS
Summary
Choline salicylate (CS) belongs to the group of non-steroidal anti-inflammatory drugs (NSAID). As a derivative of acetylsalicylic acid, CS is used for treatment in various drug forms: solid (e.g., tablets and lozenges), liquid (e.g., ear drops and nose drops), and semi-solid, such as gels. It is apparent from a review of the literature that the properties of this substance as an ionic-liquid salt are poorly understood. Q1A R2), aim to assess the susceptibility of both the active substance and the pharmaceutical form to degradation factors Such testing makes it possible to determine the appropriate storage conditions for APIs and avoid the conditions that jeopardize the stability of APIs in the prepared drug form, both during the manufacturing process and in the drug formulation [20].
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