2019
DOI: 10.1016/j.jpba.2019.02.013
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Identification and characterization of unknown degradation impurities in beclomethasone dipropionate cream formulation using HPLC, ESI-MS and NMR

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Cited by 8 publications
(7 citation statements)
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“…A large number of factors can affect the stability of a pharmaceutical product, that includes manufacturing process, stability of the molecule, storage conditions (temperature, exposure to light and humidity), as well as chemical reactions such as oxidation, reduction, hydrolysis, and racemization, which could occur after dilution of the drug before administration. The analyses carried out allowed not only the determination of the stability of the four drugs studied, but also the exclusion of degradation products, and impurities already known in literature for all tested drugs [12,15,16,21] (Figure 3).…”
Section: Resultsmentioning
confidence: 99%
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“…A large number of factors can affect the stability of a pharmaceutical product, that includes manufacturing process, stability of the molecule, storage conditions (temperature, exposure to light and humidity), as well as chemical reactions such as oxidation, reduction, hydrolysis, and racemization, which could occur after dilution of the drug before administration. The analyses carried out allowed not only the determination of the stability of the four drugs studied, but also the exclusion of degradation products, and impurities already known in literature for all tested drugs [12,15,16,21] (Figure 3).…”
Section: Resultsmentioning
confidence: 99%
“…This study aims to evaluate the stability in aerosol containers of two mucolytic agents, N-acetylcysteine (300 mg/3 ml) and ambroxol (15 mg /2ml), and two corticosteroids beclomethasone dipropionate (800 μg /2ml) and budesonide (0.50 mg /2ml and 0.25 mg /2ml), after dilution with Sirmione thermal water stored in plastic ampoules, for aerosol therapy. A large number of analytical methods for the determination and quantifi cation of N-acetylcysteine [11,12], ambroxol [13,14], budesonide [15] and beclomethasone dipropionate [16,17] in pharmaceutical preparations have been developed. However, in spite of the structural diversity and different chemical-physical properties of these drugs (Figure 1), mainly due to the presence of excipients (sodium edetate, polysorbate 80, polysorbate 20, and sorbitan laurate) that can interfere with the separation process, no method was found for their simultaneous analysis.…”
Section: Introductionmentioning
confidence: 99%
“…Stock solutions of BDP (800 µg/mL), testosterone (125 µg/mL), methylparaben (1440 µg/mL), ethylparaben (1440 µg/mL), beclomethasone (80 µg/mL), 17-BMM (400 µg/mL), and 21-BMM (400 µg/mL) were all prepared with acetonitrile. Beclomethasone, 17-BMM and 21-BMM are possible by-products produced by the hydrolysis of BDP esters in the formulations 10 11. All stock solutions were stored at room temperature and protected from light.…”
Section: Methodsmentioning
confidence: 99%
“…It is well‐known that corticosteroids act as immunomodulatory agents and possess anti‐inflammatory properties (Hotha et al, 2020). HLN is contraindicated for individuals with a history of hypersensitivity, as well as those with fungal skin diseases and untreated bacterial and viral skin diseases such as varicella, herpes simplex, and vaccinia (Sambandan et al, 2019). Stability analysis constitutes a crucial aspect of drug discovery and development.…”
Section: Introductionmentioning
confidence: 99%