Stability-Indicating Method Development and Validation of Itraconazole and Terbinafine HCL in Bulk and Pharmaceutical Tablet Dosage Form

Rode, Devyani M.; Rao, Nutan

doi:10.22159/ajpcr.2019.v12i9.33922

Cited by 5 publications

(2 citation statements)

References 3 publications

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“…The concurrent determination of TRH and ITR has been discussed in two reports [24,25]. The two reported methods are based on using acetonitrile as a main solvent.…”

Section: Introductionmentioning

confidence: 99%

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Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

et al. 2020

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In this study, determination of terbinafine and itraconazole down to biological concentration level has been carried out. The determination is based on increasing the selectivity of the spectrofluorimetric technique by combining both derivative and synchronous spectrofluorometric approaches, which permits successful estimation of terbinafine at 257 nm and itraconazole at 319 nm in the presence of each other at Δ λ of 60 nm. International Conference on Harmonization validation guidelines were followed to fully validate the method, and linearity was obtained for the two drugs over the range of 0.1–0.7 µg ml −1 for terbinafine and 0.5–4.0 µg ml −1 for itraconazole. Application of the method was successfully carried out in the commercial tablets with good agreement with the comparison spectrofluorometric methods. As the detection limits were down to 0.013 and 0.1 µg ml −1 and quantitation limits were 0.04 and 0.032 µg ml −1 for terbinafine and itraconazole, respectively; the in vitro determination of terbinafine and itraconazole in spiked plasma samples was applicable. The percentage recoveries in biological samples were 97.17 ± 4.54 and 98.75 ± 2.25 for terbinafine and itraconazole, respectively. Water was used as the optimum diluting solvent in the proposed methodology which adds an eco-friendly merit.

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“…The concurrent determination of TRH and ITR has been discussed in two reports [24,25]. The two reported methods are based on using acetonitrile as a main solvent.…”

Section: Introductionmentioning

confidence: 99%

“…The two reported methods are based on using acetonitrile as a main solvent. Additionally, the reported HPLC method [25] has a long run time (12 min). Our aim was to develop a new sensitive and smart methodology for their simultaneous quantitation.…”

Section: Introductionmentioning

confidence: 99%

Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

et al. 2020

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Ruthenium nanoparticles encrusted with nitrogen & sulphur magnetic quantum dots as an efficient electrochemical sensor for simultaneous determination of itraconazole and terbinafine; a dual regimen for black fungus: Magnetic solid phase micro-extraction for urine and plasma analysis

Ali,

El-Zahry

2024

Microchemical Journal

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Factorial design-assisted reversed phase-high performance liquid chromatography method for simultaneous determination of fluconazole, itraconazole and terbinafine

et al. 2021

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A 2 3 full factorial design model was used for the development of a new high performance liquid chromatography method with UV detection to estimate three antifungal drugs simultaneously. Fluconazole (FLU), itraconazole (ITR) and terbinafine (TRH) are co-administered for severe fungal infections. They have been determined using MOS-1 Hypersil C 18 column and an isocratic eluent; methanol 95% and phosphate buffer 5% with 0.001% triethylamine. The pH was adjusted to 7, and the flow rate was 0.7 ml min −1 . The three drugs were separated within less than 7 min at 210 nm. The developed method gave a linear response over 5–80 µg ml −1 , 5–50 µg ml −1 and 1–50 µg ml −1 for FLU, ITR and TRH, respectively. It showed detection limits of 0.88, 0.29 and 0.20 µg ml −1 and quantification limits of 2.66, 0.88 and 0.60 µg ml −1 for the three drugs, respectively. The design of the experiment facilitated the optimization of different variables affecting the separation of the three drugs. The sensitivity of the designed method permitted the simultaneous estimation of ITR and TRH in spiked human plasma successfully.

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Stability-Indicating Method Development and Validation of Itraconazole and Terbinafine HCL in Bulk and Pharmaceutical Tablet Dosage Form

Cited by 5 publications

References 3 publications

Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

Combining derivative and synchronous approaches for simultaneous spectrofluorimetric determination of terbinafine and itraconazole

Ruthenium nanoparticles encrusted with nitrogen & sulphur magnetic quantum dots as an efficient electrochemical sensor for simultaneous determination of itraconazole and terbinafine; a dual regimen for black fungus: Magnetic solid phase micro-extraction for urine and plasma analysis

Factorial design-assisted reversed phase-high performance liquid chromatography method for simultaneous determination of fluconazole, itraconazole and terbinafine

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