Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets

Dabhi, Batuk; Jadeja, Yashwantsinh; Patel, Madhavi; Jebaliya, Hetal; Karia, Denish; Shah, Anamik

doi:10.3797/scipharm.1209-15

Cited by 8 publications

(4 citation statements)

References 2 publications

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“…Only a few methods have been reported for the quantitation of dronedarone. One was specific for measurement of the drug in pharmaceutical dosage forms, with two others being intended for measurement of drug from biological matrices (Bolderman et al ., ; Dabhi et al ., ; Damy et al ., ; Xie et al ., ). Damy et al .…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of dronedarone in rat using a newly developed high‐performance liquid chromatographic assay method

Jardan

Gabr

Brocks

2014

Biomedical Chromatography

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A sensitive and selective high-performance liquid chromatographic method for the determination of dronedarone in rat plasma was developed. Dronedarone was extracted using one-step liquid-liquid extraction. The separation of dronedarone was accomplished using a C18 analytical column. The mobile phase was composed of a combination of monobasic potassium phosphate and acetonitrile. The UV detection was at 254 nm for ethopropazine, the internal standard, and after its elution, changed to 290 nm for dronedarone detection. The total analytical run time was 20 min. Mean recovery was >80%; the assay had excellent linear relationships (>0.999) between peak height ratios and plasma concentrations; the lower limit of quantification 25 was ng/mL, based on 100 μL of rat plasma. Accuracy and precision were <18% over the concentration range of 25-500 ng/mL. The assay was applied successfully to the measurement of dronedarone plasma concentrations in rats given the drug orally.

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Section: Discussionmentioning

confidence: 99%

Pharmacokinetics of dronedarone in rat using a newly developed high‐performance liquid chromatographic assay method

Jardan

Gabr

Brocks

2014

Biomedical Chromatography

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“…The solution stability was determined at MQC level (12 µg/mL) at 25 • C for 14 days and 2-8 • C for 30 days. The % recovery and % RSD of the experiment were calculated [31].…”

Section: Solution Stabilitymentioning

confidence: 99%

Optimization of Chromatographic Conditions with QbD for Method Development and Validation of Bosutinib by HPLC: Applications in Dosage Forms and Rat Plasma Analysis

Najmi,

Rehman,

Alhazmi

et al. 2023

Separations

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Aim: Bosutinib (BST) is an anti-cancer medicine that is used to treat a variety of different types of cancer. Using the HPLC method of analysis and the Quality by Design (QbD) strategy, the study aimed to precisely quantify the drug in tablet form and in rat plasma. Methodology: For the developed method’s validation, the chromatographic settings were fine-tuned by making use of the Box–Behnken Design (BBD). In the BBD, two dependent variables and three independent variables were selected. Isocratically, samples were eluted, having eluent phase composition of ammonium acetate (CH3COONH4) buffer pH 3.0 and acetonitrile (CH3CN) (60:40% v/v), in Raptor C-18 column at temperature 25 ∘C with a flow rate of 1 mL/min for 5 min. The wavelength of detection was set at 260 nm. In this study, encorafenib (ENC) was employed as an internal standard. Result: A sharp and resolved peak of BST and ENC at a retention time of 1.92 min and 4.01 min, respectively, was observed by the developed method. The limits of quantification and detection of the newly established method were found to be 1.503 μg/mL−1 and 0.496 μg/mL−1. The calibration curve’s observed linearity range was between 2 and 20 μg/mL−1, with an r2 of 0.999. The developed and optimized method was verified in compliance with the ICH guidelines. The results of all validation parameters were within the acceptable range, for example, % RSD of system suitability (0.63–4.46), % RSD of linear regression (1.659), interday and intraday precision % RSD value (1.723–1.892), and (1.762–1.923), respectively, and accuracy (1.476–1.982). Conclusion: The quantity of BST in tablet dosage form and in rat plasma samples was determined using a simple, quick, and robust method that was devised and validated.

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“…Review literature suggested that there is no single UPLC method reported for the determination of fluconazole in pharmaceutical dosage forms or in API with acidic, alkali ( Figure 5), oxidative ( Figure 6), thermal ( Figure 7), and photo degradation ( Figure 8) study. Ultraperformance liquid chromatography (UPLC) ( Figure 2) is well known and widely used analytical technique for the analysis of drug products and drug substance [17]. Current work has advantages over the earlier in terms of speed and simplicity.…”

Section: Introductionmentioning

confidence: 99%

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

Jebaliya

Patel

Jadeja

et al. 2013

Chromatography Research International

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The simplest stability indicating reversed phase Isocratic HPLC and UPLC methods has been developed and validated for the determination of fluconazole in bulk and solid pharmaceutical dosage form. A SunFire C18 (250 × 4.5 mm, 5 μm particle size) column has been used for HPLC and BEH C18 (100 × 2.1 mm, 1.7 μm particle size) column used for UPLC. The Mobile phase consisted of Methanol : Water (70 : 30) for HPLC and Methanol : Water (55 : 45 v/v) for UPLC. Isocratic flow was set at 1 mL/min and 0.30 mL/min, respectively, for HPLC and UPLC. For both HPLC and UPLC system detection has been performed at 211 nm with 30°C column oven temperature (good elution was obtained at 30°C) and injection volume, respectively, 2 μL and 20 μL for HPLC and UPLC.

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Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantitative Analysis of Dronedarone Hydrochloride in Pharmaceutical Tablets

Cited by 8 publications

References 2 publications

Pharmacokinetics of dronedarone in rat using a newly developed high‐performance liquid chromatographic assay method

Pharmacokinetics of dronedarone in rat using a newly developed high‐performance liquid chromatographic assay method

Optimization of Chromatographic Conditions with QbD for Method Development and Validation of Bosutinib by HPLC: Applications in Dosage Forms and Rat Plasma Analysis

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

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