Development and validation of an HPLC method for stability evaluation of nystatin

Cione, Ana Paola Prata; Liberale, Márcio José; Silva, Paulo Marcos da

doi:10.1590/s1984-82502010000200018

Cited by 17 publications

(12 citation statements)

References 7 publications

(4 reference statements)

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“…Several antifungal agents are used in the prevention and treatment of Candida genus, as nystatin, the most commonly used in the treatment of oral candidiasis due to its fungicidal and fungistatic characteristics (4). However, the widespread use of topical and systemic antifungal agents has resulted in the development of resistance in Candida species.…”

Section: Introductionmentioning

confidence: 99%

Interactions between Terpinen-4-ol and Nystatin on biofilm of Candida albicans and Candida tropicalis

et al. 2018

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The aim of this study was to evaluate the antifungal activity of Terpinen-4-ol associated with nystatin, on single and mixed species biofilms formed by Candida albicans and Candida tropicalis, as well as the effect of terpinen-4-ol on adhesion in oral cells and the enzymatic activity. The minimum inhibitory concentrations and minimum fungicide concentrations of terpinen-4-ol and nystatin on Candida albicans and Candida tropicalis were determined using the microdilution broth method, along with their synergistic activity (“checkerboard” method). Single and mixed species biofilms were prepared using the static microtiter plate model and quantified by colony forming units (CFU/mL). The effect of Terpinen-4-ol in adhesion of Candida albicans and Candida tropicalis in coculture with oral keratinocytes (NOK Si) was evaluated, as well as the enzymatic activity by measuring the size of the precipitation zone, after the growth agar to phospholipase, protease and hemolysin. Terpinen-4-ol (4.53 mg mL-1) and nystatin (0.008 mg mL-1) were able to inhibit biofilms growth, and a synergistic antifungal effect was showed with the drug association, reducing the inhibitory concentration of nystatin up to 8 times in single biofilm of Candida albicans, and 2 times in mixed species biofilm. A small decrease in the adhesion of Candida tropicalis in NOK Si cells was showed after treatment with terpinen-4-ol, and nystatin had a greater effect for both species. For enzymatic activity, the drugs showed no action. The effect potentiated by the combination of terpinen-4-ol and nystatin and the reduction of adhesion provide evidence of its potential as an anti-fungal agent.

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Section: Introductionmentioning

confidence: 99%

Interactions between Terpinen-4-ol and Nystatin on biofilm of Candida albicans and Candida tropicalis

et al. 2018

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“…This compound exhibits toxic effects when administered intravenously while well absorbed through healthy skin or mucous membranes. It is also considered a safe drug when treating fungal oral and intestinal infections, Chemical formula: C 47 H 75 NO 17 , Molecular mass: 926.1 g/ mol (Ghari et al, 2013;Cione et al, 2010;Groll et al, 1999) Nystatin that has name According to AUPIC system 8,12,14,16, is an antifungal drug, which was developed at the beginning of the 50 years of the last century. Nystatin is effective for treating super icial infections caused by Candida.…”

Section: Introductionmentioning

confidence: 99%

Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations

Al-Bahadily¹,

Chaloob²,

Oudah³

et al. 2019

ijrps

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In this study, a simple and reliable stability-indicating RP-HPLC method was developed and validated for the analysis of Nystatin in the pharmaceuticals. The chromatographic separation was performed in the isocratic mode on an Ion Pac column; Arcus EP‑C18; 5μm, 4.6×250 mm, 30 °C) using a mobile phase consisting of ammonium acetate 0.05 M buffer/ Methanol mixture (30:70) and a flow-rate of 1.0 mL/min with UV detection at 305 nm. The flow rate was set at 1.0 mL/min. The HPLC analysis method was validated in terms of linearity, precision, accuracy, specificity, and sensitivity, according to International Conference on Harmonization (ICH) guidelines. The results indicated that the retention time was 8 min, and no interferences were observed from the formulation excipients and stress degradation products. The specificity, linearity, precision, accuracy, LOD, and LOQ of the method were validated. The method was linear over the range of 5–500 μg/mL with an acceptable correlation coefficient (R2 = 0.9996). The method’s limit of detection (LOD) and quantification (LOQ) were 0.01 and 0.025 μg/mL, respectively. The results indicate that this validated method can be used as an alternative method for the assay of nystatin. This validated HPLC method could be used for routine analysis, quality control, and the stability of analysis of Nystatin formulations.

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“…In fact, few LC methods have been described for the control of nystatin in pharmaceutical preparations: in a mouthwash in combination with lidocaine and hydrocortisone using a gradient method;9 in a commercial ointment for a stability study but with a rapid elution which does not take into account separation of the ‘other compound’ with relative high content (max 4.0%);10 in different pharmaceutical preparations 11…”

Section: Introductionmentioning

confidence: 99%

Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

2014

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Objectives As an alternative to amphotericin B used for selective digestive decontamination, physicians asked the hospital pharmacy for the preparation of nystatin capsules 500 000 IU. Methods Three methods were considered for the routine control: liquid chromatography (LC), flow injection analysis (FIA) and ultraviolet (UV) spectrophotometry. An isocratic LC method with UV detection was developed. A Hypersil BDS C18 column (150 mm×4.6 mm, 5 mm) thermostated at 30°C was used as the stationary phase. The mobile phase was a mixture of 0.05 M ammonium acetate buffer pH 6.0 methanol (35:65, v/v). Flow rate was 1.0 mL/min and run time was 25 min. Detection was operated at 305 nm and spectra were registered between 190 and 400 nm. 10 mL were injected. FIA used LC equipment in which the stationary phase was replaced by a PEEK capillary (164 cm, 0.13 mm internal diameter) with water flow (1.0 mL/min; 25°C). 10 mL were injected. UV spectrophotometry used a double beam spectrophotometer set at 305 nm.Solutions of nystatin (reference and samples) were prepared in methanol for FIA and LC (0.36 mg/mL). For UV spectrophotometry, a subsequent dilution (1:50, v/v) with ammonium acetate buffer/methanol (50:50, v/v) was needed. Results The three methods were validated according to ICH guidelines. In the case of LC, ruggedness of the method was tested. Three batches of hospital preparations were analysed by each method. Conclusions For routine control, UV spectrophotometry or FIA would be the methods of choice (rapid, easy). The LC method could be used to perform stability studies.

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Development and validation of an HPLC method for stability evaluation of nystatin

Cited by 17 publications

References 7 publications

Interactions between Terpinen-4-ol and Nystatin on biofilm of Candida albicans and Candida tropicalis

Interactions between Terpinen-4-ol and Nystatin on biofilm of Candida albicans and Candida tropicalis

Fasten, simple, and specific stability of the avant-garde RP-HPLC method for estimation and validation of nystatin in pharmaceutical formulations

Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

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