Analytical method development and validation of hydrocortisone and clotrimazole in topical dosage form using RP-HPLC

Iqbal, Dure Najaf; Ashraf, Adeel; Iqbal, Munawar; Nazir, Arif

doi:10.1186/s43094-020-00065-7

Cited by 14 publications

(6 citation statements)

References 24 publications

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“…The extraction of analytes from the samples is based on the QuEChERS (quick, easy, cheap, effective, rugged and safe) principle. After review of the literature [4,7] we selected multiple extractions with acetonitrile with mixing on an ultrasonic bath for 10 min on room temperature. This way we achieved an adequate yield and prevented damage of the column by excipients, and the procedure is simple and fast.…”

Section: Resultsmentioning

confidence: 99%

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

Ivković

Crevar

Cvetanović³

et al. 2023

AChrom

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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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Section: Resultsmentioning

confidence: 99%

“…RP-HPLC (Reversed Phase High Performance Liquid Chromatography) with UV detection is often used for corticosteroids analysis, since it is selective, fast, sensitive and simple [3][4][5][6][7][8][9][10][11][12]. In order for the method to be used in quality control, its validation must be performed.…”

Section: Introductionmentioning

confidence: 99%

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

Ivković

Crevar

Cvetanović³

et al. 2023

AChrom

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“…According to other HPLC methods [16,17], our method uses a column temperature of 40 • C. In addition, according to the stability study of Patricia Garcia Ferreira group [18], the sample of CTZ was dried at 40 • C.…”

Section: Discussionmentioning

confidence: 99%

Development of an UPLC-MS/MS Method for Quantitative Analysis of Clotrimazole in Human Plasma Samples

2020

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An ultra-performance liquid chromatography-tandem mass spectrometry method was developed for the quantification of clotrimazole (CTZ) plasma levels after intravaginal administration of the drug given at approved dosages. Plasma samples were extracted by liquid–liquid extraction and a single chromatographic run could be completed within about 2 min. The method was linear over the investigated range (0.488–250 ng/mL) with all the correlation coefficients, R2, greater than 0.9903. All data were in the range of ±15.0% with respect to the nominal concentration for high QC and medium QC, and in the range ±20% with respect to the nominal concentration for low QC. This rapid and sensitive method was validated and could be applied to human plasma samples from a healthy volunteer, showing that the assay is able to detect plasma concentrations of CTZ in the range of those found after the administration of the drug at approved dosages in the clinical setting.

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“…6 Topical therapy modalities offer a number of advantages over alternative delivery methods, including non-invasiveness, usability, targeting infection areas, less side effects and interactions between drugs, increased patient compliance, and more cost treatment. 7 In comparison to oral pharmaceutical therapy, these properties make topical therapy an appropriate therapeutic option for superficial cutaneous fungal infections. Targeted skin areas can simply receive appropriate concentrations of antifungal medicines with topical therapy if drug release and penetration are sufficiently managed.…”

Section: Introductionmentioning

confidence: 99%

Design and Development of Anti-fungal Topical Gel Loaded with Solid Lipid Nanoparticles for Wound Healing

Meravanige,

Ranjitha B,

Goudanavar

et al. 2023

Ind. J. Pharm. Edu. Res

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Background:The topical administration of antifungal drugs by Solid Lipid Nanoparticles (SLNs) has enormous potential. This study aimed to develop a topical 5-flucytosine-loaded SLNs gel to improve the efficacy of the well-known antifungal drug in the treatment of wound healing. Materials and Methods: In order to create 5-flucytosine SLNs, a five-level, two-factor Central-composite design was used. Stearic acid and Poloxamer 407 concentrations of surfactants were chosen as independent factors, and particle size and %Entrapment Efficiency (%EE) were chosen as dependent variables. The produced 5-Flucytosine-SLNs were examined using SEM analysis, zeta potential, polydispersity index, and particle size measurements. Additionally, Carbopol 934 was used to incorporate the improved 5-Flucytosine-SLN formula into gel. Results: The outcomes demonstrated that 5-Flucytosine-SLNs had colloidal sizes with an essentially spherical shape and no aggregation. 5-Flucytosine-SLNs were discovered to have a particle size of 720.4 nm and an Entrapment Efficiency (EE) of 90.28%. The in vitro release, among other assessment criteria, was evaluated for the improved SLN gels. Conclusion: The study's conclusions imply that the topical gels made with 5-Flucytosine-loaded SLNs must be effective in the management of wound healing.

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Analytical method development and validation of hydrocortisone and clotrimazole in topical dosage form using RP-HPLC

Cited by 14 publications

References 24 publications

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

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

Development of an UPLC-MS/MS Method for Quantitative Analysis of Clotrimazole in Human Plasma Samples

Design and Development of Anti-fungal Topical Gel Loaded with Solid Lipid Nanoparticles for Wound Healing

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