Validated HPLC method for simultaneous determination of azelastine hydrochloride fluticasone propionate and oxymetazoline in nasal mucosa and nasopharyngeal swabs from real human samples.

Publication date: Feb 04, 2025

A combination of three co-administrated drugs, such as azelastine hydrochloride (AZT), fluticasone propionate (FP), and oxymetazoline (OXY), is more effective than single therapy for the treatment of seasonal allergy and COVID-19. We established an efficient methodology for the determination of those analytes in spiked nasal mucosa and nasopharyngeal swabs from real human samples. A simple and quick protein precipitation method was used for sample extraction, using acetonitrile. RP-HPLC/DAD method was performed using an Exsil 100 ODS C18 (250 cD7 4. 6 mm, 5 μm) column with an acetonitrile: water (70:30 v/v) solvent system at a flow rate of 0. 7 mL/min. A photodiode array detector was applied at 240 nm. A good separation of the three proposed analytes with a short run time of 10 min was noted. Our method was validated according to FDA guidelines for bioanalytical validation methods. Calibration curves were linear in nasal mucosa samples at concentration ranges of 8-125, 10-100, and 10-125 ug/mL, with average recoveries +/- SD of 101. 56%+/-0. 39, 102. 45%+/-0. 86, and 104. 61%+/-4. 52 for AZT, FP, and OXY; respectively. The results of precision and accuracy are within acceptable limits. According to stability assays, the three analytes under investigation were stable throughout sample preparation, storage, and injection. Our method was applied to real nasopharyngeal swabs. It shows that the results of the swabs were not affected by gender or age. Good recoveries with low % RSD were observed: 99. 03% +/- 0. 75, 100. 02% +/- 0. 94, and 100. 94% +/- 1. 98 for both genders, and 100. 45% +/- 0. 96, 100. 69% +/- 1. 08, and 100. 32% +/- 1. 53 for different ages for AZT, FP, and OXY; respectively. Moreover, the amount of those drugs in the nasal mucosa was observed for seven hours, and a constant concentration with a low% RSD was noted for the first four hours. Therefore, this method can be applied to monitor the therapeutic dose in the nasal mucosa for the determination of those analytes.

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Concepts Keywords
10min Adult
Dad azelastine
Efficient Azelastine hydrochloride
Oxymetazoline COVID-19 Drug Treatment
Therapy Female
Fluticasone
Fluticasone
Fluticasone propionate
HPLC
Humans
Male
Middle Aged
Nasal Mucosa
Nasal mucosa
Nasopharyngeal swabs
Nasopharynx
Oxymetazoline
Oxymetazoline
Oxymetazoline
Phthalazines
Phthalazines
Seasonal allergy

Semantics

Type Source Name
drug DRUGBANK Fluticasone propionate
drug DRUGBANK Oxymetazoline
drug DRUGBANK Zidovudine
disease MESH allergy
disease MESH COVID-19
disease IDO protein
drug DRUGBANK Water
disease MESH rhinitis
disease MESH inflammation
drug DRUGBANK Diphenylpyraline
disease IDO intervention
drug DRUGBANK Coenzyme M
disease MESH nasal blockage
disease IDO algorithm
drug DRUGBANK Azelastine
disease MESH syndrome
disease IDO production
drug DRUGBANK Hydrocortisone
drug DRUGBANK Fluticasone
disease MESH aids
disease IDO process
disease IDO assay
drug DRUGBANK Flunarizine
disease MESH Allergic rhinitis
disease MESH asthma
pathway KEGG Asthma
disease MESH seasonal allergic rhinitis
drug DRUGBANK Bismuth subgallate
disease MESH complications
disease MESH viral load
drug DRUGBANK Ciclesonide
disease MESH anosmia
drug DRUGBANK Triamcinolone
disease MESH dysgeusia
pathway REACTOME Adrenoceptors
disease MESH Epistaxis
drug DRUGBANK Ethanol
pathway REACTOME Reproduction

Original Article

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