A Comparative Validation Study of Fluconazole by HPLC and UPLC with Forced Degradation Study

Jebaliya, Hetal; Patel, Madhavi; Jadeja, Yashwant; Dabhi, Batuk; Shah, Anamik

doi:10.1155/2013/673150

Cited by 10 publications

(4 citation statements)

References 13 publications

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“…Admitting the previously mentioned AOAC acceptance criteria, the developed method is not able to adequately determine the drugs after their degradation [40,42], except FL exposure at alkaline pH. It is suggested that the low percentage of recovery after the stress study is due to the high degradation of FL and CUR under the analyzed conditions, similar to that was observed in the studies conducted by Jebaliya et al [43], and Syed et al [44]. Thus, based on the results obtained, the proposed method is not suitable for the quantification of CUR and FL under conditions of photolysis, oxidative damage, and degradation in alkaline and acidophilic mediums.…”

Section: Stress Testmentioning

confidence: 70%

Validation of an innovative analytical method for simultaneous quantification of curcumin and fluconazole using high‐performance liquid chromatography from nanostructured lipid carriers

Araújo

Fernandes

Reis

et al. 2021

J of Separation Science

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Vulvovaginal candidiasis is a public health problem with a high incidence among female patients. Currently, there is an increase in the identification of Candida spp. resistant to current therapy, making it necessary to search for new therapeutic alternatives. The synergistic potential of curcumin with fluconazole is described in the literature. However, due to its high lipophilicity, it is necessary to use drug-delivery systems to adequately explore its potential, among which is the nanostructured lipid carrier. However, to date, there is no validated method of high-performance liquid chromatography for simultaneous determination of fluconazole and curcumin in the literature. Thus, the present work developed a high-performance liquid chromatography method for simultaneous determination of fluconazole and curcumin co-encapsulated in nanostructured lipid carrier which was validated according to the International Conference on Harmonization (Technical Requirements for Registration of Pharmaceuticals for Human Use) -Q2 (R1) and the Food and Drug Administration -Guidance for Bioanalytical Method. The method was applied to determine the encapsulation efficiency and drug-loading of curcumin and fluconazole in nanostructured lipid carriers.The developed method proved to be selective, precise, accurate, and robust for the simultaneous determination of both drugs, enabling the quantification of encapsulation efficiency and drug-loading of curcumin and fluconazole in nanostructured lipid carriers.

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Section: Stress Testmentioning

confidence: 70%

Validation of an innovative analytical method for simultaneous quantification of curcumin and fluconazole using high‐performance liquid chromatography from nanostructured lipid carriers

Araújo

Fernandes

Reis

et al. 2021

J of Separation Science

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“…Eight milliliters of phosphate buffered saline (pH 6.8) prepared from disodium hydrogen phosphate (Na 2 HPO 4 anhydrous) = 14.4 g sodium dihydrogen phosphate (KH 2 PO 4 anhydrous) = 2.4 g sodium chloride (NaCl) = 80.0 g, and potassium chloride (KCl) = 2.0 g, was kept in the receptor chamber, which was maintained at 32 ± 2 °C with the help of a warm water jacket and stirred at 410 to 430 rpm using the magnetic bead. The samples were autosampled at predetermined time intervals and quantified in parallel using high-performance liquid chromatography (HPLC) [ 22 ]. Diffusion of the fluconazole from the donor compartment to the receptor compartment through the mounted mucous membrane was determined by plotting the cumulative release pattern of the drug per unit of time and area.…”

Section: Methodsmentioning

confidence: 99%

Oral Gel Loaded by Fluconazole‒Sesame Oil Nanotransfersomes: Development, Optimization, and Assessment of Antifungal Activity

2020

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Candidiasis is one of the frequently encountered opportunistic infections in the oral cavity and can be found in acute and chronic presentations. The study aimed to develop fluconazole-loaded sesame oil containing nanotransfersomes (FS-NTF) by the thin-layer evaporation technique to improve the local treatment of oral candidiasis. Optimization of the formulation was performed using the Box‒Behnken statistical design to determine the variable parameters that influence the vesicle size, entrapment efficiency, zone of inhibition, and ulcer index. Finally, the formulated FS-NTF was embedded within the hyaluronic acid‒based hydrogel (HA-FS-NTF). The rheological behavior of the optimized HA-FS-NTF was assessed and the thixotropic behavior with the pseudoplastic flow was recorded; this is desirable for an oral application. An in vitro release study revealed the rapid release of fluconazole from the HA-FS-NTF. This was significantly higher when compared with the fluconazole suspension and hyaluronic acid hydrogel containing fluconazole. Correspondingly, the ex vivo permeation was also found to be higher in HA-FS-NTF in sheep buccal mucosa (400 μg/cm2) when compared with the fluconazole suspension (122 μg/cm2) and hyaluronic acid hydrogel (294 μg/cm2). The optimized formulation had an inhibition zone of 14.33 ± 0.76 mm and enhanced antifungal efficacy for the ulcer index (0.67 ± 0.29) in immunocompromised animals with Candida infection; these findings were superior to those of other tested formulations. Hence, it can be summarized that fluconazole can effectively be delivered for the treatment of oral candidiasis when it is entrapped in a nanotransfersome carrier and embedded into cross-linked hyaluronic acid hydrogel.

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“…It is widely used to treat fungal infections caused by cryptococci, candida and coccidia, and it is official in Indian Pharmacopoeia 1 . The most commonly used techniques for determining FLU in pharmaceutical dosage forms and biological fluid are the UV-Spectrophotometric [22][23] , HPLC [24][25][26][27] , UPLC 28 and LC-MS [29][30] .…”

Section: Introductionmentioning

confidence: 99%

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

Raskar,

Kate,

Mungse

et al. 2023

J. Drug Delivery Ther.

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Two simple, sensitive, accurate and precise spectrophotometric methods were developed and validated for the quantitative determination of Azithromycin (AZI), Fluconazole (FLU) and Secnidazole (SEC) in bulk and tablet dosage form. Method A is based on the first-order derivative (D1) and Method B is based on the second-order derivative (D2) spectrophotometric method. In Method A, absorbance was measured at 215nm, 275nm and 333nm being the zero crossing points for AZI, FLU and SEC respectively. In Method B, absorbance was measured at 220nm, 225nm and 211nm being the zero crossing points for AZI, FLU and SEC respectively. For Method A, all three drugs obey Beer’s law in the concentration range 5-30µg/ml for AZI, 5-60 µg/ml for FLU and 5-40 µg/ml for SEC with correlation coefficients 0.995, 0.998 and 0.998 respectively. For Method B, all three drugs obey Beer’s law in the concentration range 5-35 µg/ml for AZI, 5-40 µg/ml for FLU and 5-40 µg/ml for SEC with correlation coefficients 0.995, 0.999 and 0.998 respectively. Both methods can be used for routine analysis of these three drugs in their pharmaceutical dosage form. Results for analysis of both methods were tested and validated for various parameters according to ICH guidelines. Keywords: Derivative, Azithromycin, Fluconazole, Secnidazole

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A Comparative Validation Study of Fluconazole by HPLC and UPLC with Forced Degradation Study

Cited by 10 publications

References 13 publications

Validation of an innovative analytical method for simultaneous quantification of curcumin and fluconazole using high‐performance liquid chromatography from nanostructured lipid carriers

Validation of an innovative analytical method for simultaneous quantification of curcumin and fluconazole using high‐performance liquid chromatography from nanostructured lipid carriers

Oral Gel Loaded by Fluconazole‒Sesame Oil Nanotransfersomes: Development, Optimization, and Assessment of Antifungal Activity

Validated Simultaneous Derivative Spectrophotometric Estimation of Azithromycin, Fluconazole and Secnidazole in Bulk and Pharmaceutical Formulation

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