An optimized analytical method of fluconazole in human plasma by high-performance liquid chromatography with ultraviolet detection and its application to a bioequivalence study

Kim, Sung‐Su; Im, Ho-Taek; Kang, Il-Mo; Lee, Hyun Su; Lee, Heon-Woo; Cho, Sung-Hee; Kim, Jongbin; Lee, Kyung‐Tae

doi:10.1016/j.jchromb.2007.01.012

Cited by 35 publications

(16 citation statements)

References 14 publications

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“…Fluconazole, a triazole agent, is one of the most commonly prescribed systemic antifungals (Koks et al, 1996;Marchetti et al, 2001;Kim et al, 2007). It is well absorbed after oral administration and shows good penetration into cerebrospinal fluid (Harris et al, 1999).…”

Section: Introductionmentioning

confidence: 99%

“…It is important to mention that capsules with dosage lower than that recommended are ineffective and compromise patient health. Studies focused on fluconazole determination in pharmaceutical formulation by bioassay are scarce, where the majority of papers are related to its study in clinical samples using a HPLC method (blood, serum, saliva or skin) (Harris et al, 1989;Rex et al, 1991;GarciaHermoso et al, 1995;Koks et al, 1996;Hülsewede and Dermoumi, 1996;Cohen et al, 1997;Moraes et al, 1999;Abdel-Moety et al, 2002;Mathy et al, 2003;Marchetti et al, 2003;Porta et al, 2005;Kim et al, 2007;Lima et al, 2009). …”

Section: Introductionmentioning

confidence: 99%

“…The most commonly described assay for fluconazole content in capsules are high performance liquid chromatography (HPLC), gas liquid chromatography and spectrophotometry (Harris et al, 1989;Rex et al, 1991;Moraes et al, 1999;Porta et al, 2005;Kim et al, 2007). These methods require expensive equipment and considerable technician time (Rex et al, 1991).…”

Section: Introductionmentioning

confidence: 99%

“…Studies of fluconazole determination in pharmaceutical capsules have used mainly HPLC and UV (Abdel-Moety et al, 2002;Porta et al, 2005;Kim et al, 2007), while microbiological method use is scarce. This assay can reveal subtle changes not demonstrable by chemical methods.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of microbiological assay and HPLC-UV for determination of fluconazole in capsules

Queiroz

Silva

Prado

et al. 2009

Braz. J. Pharm. Sci.

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The development of a specific agar diffusion bioassay for the quantitative determination of fluconazole formulated in capsules was carried out using a strain of Candida albicans ATCC 18804 as the test organism. A prospective validation of the method showed adequate linearity (r 2 =0.9995), precision (R.S.D. = 4.0% for intra-day and 4.5% for inter-day precision) and accuracy (mean recovery = 102.9%). High performance liquid chromatography was chosen as a comparison method for the fluconazole determination. The contents of fluconazole determined by both methods, for four capsule samples, showed a strong correlation, confirmed by Pearson's correlation coefficient value (r = 0.9884). The bioassay is a suitable method for both research and pharmaceutical industry laboratories.Uniterms: Fluconazole/quantitative determination. Microbiological assay/agar diffusion. High performance liquid chromatography.Este trabalho visou ao desenvolvimento e validação de um método microbiológico por difusão em ágar para quantificação de fluconazol em cápsulas utilizando o isolado Candida albicans ATCC 18804 como reagente biológico. O método foi validado e foi verificada linearidade (r 2 =0,9995), precisão (D.P.R. = 4.0% para precisão intra-dia e 4,5% para precisão inter-dia) e exatidão (recuperação média = 102,9%). Concomitantemente, foi realizado o doseamento de fluconazol nas cápsulas por meio de cromatografia líquida de alta eficiência. Os teores encontrados por ambos os métodos demonstraram alta correlação, confirmada pelo Coeficiente de Correlação de Pearson (r = 0,9884). O ensaio microbiológico desenvolvido pode ser considerado ferramenta valiosa tanto para a pesquisa científica quanto para a rotina da indústria farmacêutica.Unitermos: Fluconazol/quantificação. Ensaio microbiológico/por difusão em ágar. Cromatografia líquida de alta eficiência.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of microbiological assay and HPLC-UV for determination of fluconazole in capsules

Queiroz

Silva

Prado

et al. 2009

Braz. J. Pharm. Sci.

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“…The present study is an attempt to develop LC/MS/MS method for the determination of both the genotoxic impurity and its precursor. The literature survey revealed that some spectrophotometric and HPLC methods were developed for the determination of fluconazole in formulations as well as bio samples [21][22][23][24][25][26][27][28], but no method has been found for the determination of genotoxic impurities at low levels (µg/g).…”

Section: Introductionmentioning

confidence: 99%

Method Development and Validation Study for Quantitative Determination of Genotoxic Impurity and Its Precursor in Fluconazole Sample by Liquid Chromatography–tandem Mass Spectrometry

Devanna

Reddy

2016

Int J Pharm Pharm Sci

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Objective: The objective of this work is method development and validation study for quantitative determination of 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-triazole, a genotoxic impurity and its precursor in a fluconazole drug sample by liquid chromatography-tandem mass spectrometry.Methods: LC-MS/MS analysis of these impurities was performed on Hypersil BDS C18 (100 mm x 4.0 mm, 3 µm) column. 5 mmol ammonium acetate and acetonitrile in the ratio of 65:35 (v/v) was used as the mobile phase with a flow rate of 0.4 ml/min. The developed method was accomplished with a short run time of 10 min. Triple quadrupole mass detector coupled with positive electrospray ionization was used for the quantification of genotoxic impurities in multiple reaction monitoring (MRM). Results:The method was validated as per International Conference on Harmonization (ICH) guidelines. The method was linear in the range of 0.30 µg/g to 11.37 µg/g for impurity A and 0.30 µg/g to 11.34 µg/g for impurity B with a correlation coefficient of 0.999. The accuracy of the method was in the range of 98.25 % to 100.53 % for both impurities. Conclusion:A specific, selective, highly sensitive and more accurate analytical method using LC-MS/MS coupled with positive electrospray ionization has been developed for the quantification of genotoxic impurity (1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-triazole) and its precursor (1-(2,4-difluorophenyl)-2-[1,2,4]triazol-1-yl-ethanone) at 0.3 µg/g with respect to the 5.0 mg/ml of fluconazole.

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Famotidine

2010

Analytical Methods for Therapeutic Drug Monitoring and Toxicology

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An optimized analytical method of fluconazole in human plasma by high-performance liquid chromatography with ultraviolet detection and its application to a bioequivalence study

Cited by 35 publications

References 14 publications

Comparison of microbiological assay and HPLC-UV for determination of fluconazole in capsules

Comparison of microbiological assay and HPLC-UV for determination of fluconazole in capsules

Method Development and Validation Study for Quantitative Determination of Genotoxic Impurity and Its Precursor in Fluconazole Sample by Liquid Chromatography–tandem Mass Spectrometry

Famotidine

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