RP-HPLC method for quantitative estimation of Efinaconazole in topical microemulsion and microemulsion-based-gel formulations and in presence of its degradation products

Agrawal, Vikas; Patel, Rajesh; Mrunali, Patel; Mishra, Susmita; Thanki, Kaushik

doi:10.1016/j.microc.2020.104753

Cited by 15 publications

(7 citation statements)

References 15 publications

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“…The results were analyzed by determining the standard deviation of all the parameters of the system suitability study. The acceptance criteria and the limits for RSD were in concordance to USP limits [15][16][17].…”

Section: System Suitabilitysupporting

confidence: 67%

“…The peak area of all six solutions, detected at a λ max of 252.0 nm, and % relative standard deviation (RSD) was calculated from the recorded chromatograms. The acceptance criteria for the %RSD was kept as ≤ 2% [16,18].…”

Section: Methods Precisionmentioning

confidence: 99%

“…The results were recorded for the regression coefficient (R 2 ), the slope of the regression line, and the y-intercept. The R 2 > 0.999 was set as the acceptance criteria for the linearity of the developed method [16].…”

Section: Linearity and Rangementioning

confidence: 99%

“…Accuracy is defined as the closeness of the test value of the method in comparison with the expected value. It is calculated in terms of percentage recovery of the analyte using the following equation [16].…”

Section: Accuracy (Percentage Recovery)mentioning

confidence: 99%

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RP-HPLC method development and validation for the quantification of Efonidipine hydrochloride in HME processed solid dispersions

et al. 2020

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Background Efonidipine hydrochloride (EFO) is a poorly water-soluble drug and, hence, has poor bioavailability. Solid dispersions (SDs) of EFO using Eudragit EPO were prepared using hot-melt extrusion (HME) for the first time. The current study aims at developing a simple RP-HPLC method to quantify EFO in the developed SDs. Results The chromatographic separation was carried out on an Agilent Eclipsed XDB-C18 column (4.6 × 250 mm), packed with 5 μm particles. The optimized mobile phase consisted of HPLC grade acetonitrile and 0.020 mol/L KH2PO4 (pH 2.5) buffer in the ratio of 85:15 v/v with a flow rate optimized at 1.2 ml/min. The developed method was validated for system suitability, linearity, accuracy, precision, and robustness. The linearity results showed an excellent linear relationship between the drug concentration and peak area, indicating the peak area is directly proportional to the analyte concentration within a specific range and an excellent correlation coefficient of 0.9998. Intermediate precision and repeatability confirmed that the method provides precise results with %RSD value less than 2% for EFO. The assay results of the developed formulations were in the acceptable range with RSD less than 2%. The enhanced drug dissolution from the Eudragit EPO carrier with 10% Citric Acid (CA) is attributed to the conversion of the drug from crystalline to amorphous form, and microenvironmental acidic pH provided by CA. Conclusion In a nutshell, the developed RP-HPLC method showed excellent ability to differentiate the formulations and highlights the role of the polymer and the plasticizer. Graphical abstract

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Section: System Suitabilitysupporting

confidence: 67%

Section: Methods Precisionmentioning

confidence: 99%

Section: Linearity and Rangementioning

confidence: 99%

Section: Accuracy (Percentage Recovery)mentioning

confidence: 99%

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RP-HPLC method development and validation for the quantification of Efonidipine hydrochloride in HME processed solid dispersions

et al. 2020

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“…The drug content in each formula was determined using HPLC analysis previously reported, with slight modifications [ 30 ]. Each sample (100 µL) was 1,000-fold diluted with acetonitrile (ACN) and injected into a Shimadzu HPLC system (Shimadzu, Kyoto, Japan) equipped with a pump (LC-20AD XR), autosampler (SIL-20AC XR), UV–VIS detector SPD-M20A), and system controller (CBM-20A).…”

Section: Methodsmentioning

confidence: 99%

Effect of Penetration Enhancers on Toenail Delivery of Efinaconazole from Hydroalcoholic Preparations

Park

Kim

et al. 2021

Molecules

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The incorporation of permeation enhancers in topical preparations has been recognized as a simple and valuable approach to improve the penetration of antifungal agents into toenails. In this study, to improve the toenail delivery of efinaconazole (EFN), a triazole derivative for onychomycosis treatment, topical solutions containing different penetration enhancers were designed, and the permeation profiles were evaluated using bovine hoof models. In an in vitro permeation study in a Franz diffusion cell, hydroalcoholic solutions (HSs) containing lipophilic enhancers, particularly prepared with propylene glycol dicaprylocaprate (Labrafac PG), had 41% higher penetration than the HS base. Moreover, the combination of hydroxypropyl-β-cyclodextrin with Labrafac PG further facilitated the penetration of EFN across the hoof membrane. In addition, this novel topical solution prepared with both lipophilic and hydrophilic enhancers was physicochemically stable, with no drug degradation under ambient conditions (25 °C, for 10 months). Therefore, this HS system can be a promising tool for enhancing the toenail permeability and therapeutic efficacy of EFN.

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Development and validation of HPLC methodology for quantitative estimation of Efinaconazole in topical pharmaceutical formulation prepared in‐house for the treatment of onychomycosis

Patani

Patel

2020

Separation Science Plus

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The purpose of this research work was to design, develop, and optimize new high‐performance liquid chromatography method for quantitative estimation of Efinaconazole in topical pharmaceutical formulation developed in‐house for the treatment of onychomycosis. Based on the outcomes of preliminary investigation, optimized high‐performance liquid chromatography conditions were reverse phase column (Luna C18) as stationary material, with simple isocratic mobile phase comprising mixture of water and acetonitrile (20:80 v/v), flow rate 1 mL/min, column oven temperature 30°C, injection volume 10 µL, detection wavelength of 230 nm, and total run time of 10 min. The optimized method was successfully validated as per International Council for Harmonization guideline Q2(R1), and statistical analysis proved that the method is specific (peak purity ≥ 0.999), accurate (99.21–99.63% w/w), precise (% relative standard deviation < 2.0), and sensitive (limit of detection = 9.26 µg and limit of quantitation = 28.05 µg). As a result, this research work provides a new and simple high‐performance liquid chromatography methodology with optimized chromatographic parameters for quantitation of Efinaconazole as a routine assay purpose, contributing to the technological and scientific domain and guaranteeing a safe and effective use of Efinaconazole for the treatment of onychomycosis.

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RP-HPLC method for quantitative estimation of Efinaconazole in topical microemulsion and microemulsion-based-gel formulations and in presence of its degradation products

Cited by 15 publications

References 15 publications

RP-HPLC method development and validation for the quantification of Efonidipine hydrochloride in HME processed solid dispersions

RP-HPLC method development and validation for the quantification of Efonidipine hydrochloride in HME processed solid dispersions

Effect of Penetration Enhancers on Toenail Delivery of Efinaconazole from Hydroalcoholic Preparations

Development and validation of HPLC methodology for quantitative estimation of Efinaconazole in topical pharmaceutical formulation prepared in‐house for the treatment of onychomycosis

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