Development and validation of RP-HPLC method for quantification of trace levels of topical corticosteroids in ambiphilic cream

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Abstract

Corticosteroids are anti-inflammatory and immunosuppressant drugs. Topical corticosteroids formulations (ointments, creams, gels) are used in the treatment of different types of dermatitis and urticaria. Considering their therapeutic and whitening effects, they are frequently used for counterfeiting of cosmetic products. Corticosteroids can cause different local and systemic side effects. HPLC method is often chosen for their analysis, because it is selective, sensitive, precise, simple and fast.

The aim of this study was optimization and validation of RP-HPLC method with UV detection for determination of trace levels of corticosteroids in ambiphilic creams. This method is used for qualitative and quantitative analysis of evaluated corticosteroids.

Mometasone furoate, hydrocortisone acetate, fluocinonide, fluocinolone acetonide, betamethasone, betamethasone dipropionate and triamcinolone acetonide were evaluated. Separation was performed on Inertsil® ODS-3V 250 × 4.6 mm, 5 μm chromatographic column. Mobile phase was mixture of acetonitrile and water 50:50 (v/v) with gradient elution and flow rate 1 mL min ⁻¹. Column temperature was held on 40 °C and UV detection was performed at 240 nm.

Selectivity, linearity, accuracy, precision and limit of quantification (LOQ) were evaluated. Method is selective because ambiphilic cream base peaks and corticosteroids peaks were not overlapping. Linearity was confirmed since correlation coefficient was 1 for all compounds. Accuracy and precision were evaluated for hydrocortisone acetate and betamethasone dipropionate. Determined Recovery values were in range of 70–130%. Both RSD values (21.46% and 9.59%) were lower than 30%. Method is highly sensitive since LOQ concentrations were in ng mL ⁻¹ range.

All evaluated parameters of validation were in accordance with regulatory requirements. Validated RP-HPLC method can be used for qualitative and quantitative analysis of selected corticosteroids in ambiphilic creams.

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Author and article information

Contributors

Branka Ivković

Milkica Crevar:

ORCID: 0000-0002-6947-4824

Anka Cvetanović

Katarina Ubavkić

Bojan Marković

Journal

Journal ID (publisher-id): 1326

Title: Acta Chromatographica

Abbreviated Title: AChrom

Publisher: Akadémiai Kiadó (Budapest )

ISSN (Print): 1233-2356

ISSN (Electronic): 2083-5736

Publication date (Electronic): 03 February 2022

Affiliations

[1 ] Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Belgrade , Vojvode Stepe 450, Belgrade, Serbia

[2 ] PrimeVigilance d.o.o. , Đorđa Stanojevića br. 14, Belgrade, Serbia

[3 ] Apoteka Privatna Praksa Iris SM 2015 , Pop Lukina br. 1, Belgrade, Serbia

Author notes

[* ]Corresponding author. University of Belgrade, Faculty of Pharmacy, Department of Pharmaceutical Chemistry , Vojvode Stepe 450, 11221, Belgrade, Serbia. Tel.: +381692604981. E-mail: milkica@ 123456pharmacy.bg.ac.rs

Article

DOI: 10.1556/1326.2021.00998

SO-VID: 208be673-2157-4b3c-b6d8-3a587ae637bb

License:

Open Access. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes – if any – are indicated.