Development and Validation of rp-HPLC Method of Cabozantinib in Active Pharmaceutical Ingredient and Pharmaceutical Dosage form

Chaudhary, Amruta A.; Shelke, Ashwini; Jadhav, Anil G.

doi:10.9734/jpri/2021/v33i1131247

Cited by 5 publications

(4 citation statements)

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“…The RSD% of the intermediate precision did not exceed the value range of the RSDr% calculated according to the Horwitz equation. The content of phenolic compounds in the matrix of American cranberry fruit makes up a small part of all the components of the matrix, and therefore the calculated permissible values of RSDr% deviation were higher (5.67-8.09%) than the 2% deviation limit often recommended in literature [50,53,58,59].…”

Section: Precisionmentioning

confidence: 81%

Development, Validation, and Application of the UPLC-DAD Methodology for the Evaluation of the Qualitative and Quantitative Composition of Phenolic Compounds in the Fruit of American Cranberry (Vaccinium macrocarpon Aiton)

et al. 2022

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Phenolic compounds in the fruit of American cranberry (Vaccinium macrocarpon Aiton) determine the antioxidant, anti-inflammatory, anticancer, and other biological effects. The berries are used in the production of medicinal preparations and food supplements, which highlights the importance of qualitative and quantitative analysis of phenolic compounds in cranberry fruit raw material. The aim of our study was to develop and validate an efficient, cost-effective, reproducible, and fast UPLC-DAD methodology for the evaluation of the qualitative and quantitative composition of phenolic compounds in raw material and preparations of American cranberry fruit. During the development of the methodology, chlorogenic acid and the following flavonols were identified in cranberry fruit samples: myricetin-3-galactoside, quercetin-3-galactoside, quercetin-3-glucoside, quercetin-3-α-L-arabinopyranoside, quercetin-3-α-L-arabinofuranoside, quercetin-3-rhamnoside, myricetin, and quercetin. The developed and optimized UPLC-DAD methodology was validated according to the guidelines of the International Council for Harmonization (ICH), evaluating the following parameters: range, specificity, linearity (R2 > 0.999), precision (%RSD < 2%), LOD (0.38–1.01 µg/mL), LOQ (0.54–3.06 µg/mL), and recovery (80–110%). The developed methodology was applied to evaluate the qualitative and quantitative composition of phenolic compounds in fruit samples of cranberry cultivars ‘Baifay’, ‘Bergman’, ‘Prolific’, and ‘Searles’, as well as ‘Bain-MC’ and ‘BL-12′ clones. In the tested samples, the majority (about 70%) of the identified flavonols were quercetin derivatives. The greatest amount of quercetin-3-galactoside (1035.35 ± 4.26 µg/g DW) was found in fruit samples of the ‘Searles’ cultivar, and the greatest amount of myricetin-3-galactoside (940.06 ± 24.91 µg/g DW) was detected in fruit samples of the ‘Woolman’ cultivar.

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Section: Precisionmentioning

confidence: 81%

Development, Validation, and Application of the UPLC-DAD Methodology for the Evaluation of the Qualitative and Quantitative Composition of Phenolic Compounds in the Fruit of American Cranberry (Vaccinium macrocarpon Aiton)

et al. 2022

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“…There are seven different methods [61,[65][66][67][68][69] with different applications like determination in API and/or dosage forms [61,[65][66][67][68][69], related substance [68], dissolution studies [68] or in combinations. The recently developed LC-MS/MS method [69] with LOD and LOQ of 1.5 ng/ml and 5 ng/ml, respectively, is the most sensitive method in this segment.…”

Section: Determination In Marketed Formulationsmentioning

confidence: 99%

Mechanism of Action, Synthesis, Properties and Analytical Methods of Cabozantinib

DWIVEDI¹,

KHABIYA²,

Shrivastava³

et al. 2023

Int J App Pharm

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Globally, the burden of cancer is substantial and growing. The impact of the burden of such diseases over society is unpredictable in terms of health lost and cost. Unfortunately, the estimates shown the burden may be increasing in the upcoming decades. Cabozantinib (CBZ) is a newly developed tyrosin kinase inhibitor (TKI) for Differentiated thyroid cancer (DTC), Hepatic Cellular Carcinoma (HCC), Medullary thyroid cancer (MTC) and Renal Cell Carcinoma (RCC). The objective of the presented review is to provide updated knowledge of drugs especially covering analytical methodologies. The review covered the introduction, mechanism of action, pharmacokinetics, synthesis and developed analytical methods by various researchers. The review covered one spectrophotometry and about twenty chromatography methods. The review will be helpful for the scientist working in this area and especially helpful for analytical scientists exploring new analytical methodologies for CBZ.

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“…Inter-day studies were determined by evaluating single sample solution (6 ppm) for six consecutive days, whereas intra-day studies were determined by evaluating single sample solutions (6 ppm) for six times on the same day. We determined the mean, standard deviation, and % RSD [12].…”

Section: Precisionmentioning

confidence: 99%

“…The method's robustness was tested by determining CL with a flow rate of 0.9 ml/min instead of 1 ml/min. After that, the data was statistically analyzed, and the results were represented in terms of mean, standard deviation, and % RSD [12].…”

Section: Ruggednessmentioning

confidence: 99%

Development and Validation of Ultraviolet and Reverse Phase-high Performance Liquid Chromatographic Method for Estimation of Cilnidipine

Samantaray

Panda

Mahapatra³

et al. 2021

JPRI

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Aim: The current experiment was to develop and validate a straight forward RP-HPLC methodology for the determination of Cilnidipine. Methodology: UV spectroscopy was used to estimate Cilnidipine. Action separation of Cilnidipine was achieved by employing a C18 column. Mobile phase combination of methanol: water (90:10 v/v) was tense at the flow of 1 ml/min. Detection was performed at 241 nm. Validation parameters were evaluated in line with the International conference on harmonization (ICH) Q2R1 guidelines. Results: The standardization curve was linear within the varying concentration of 2-10 mg/ml for Cilnidipine with parametric statistic (r2) equal to 0.999. The tactic was found to be accurate (101.66% recovery), precise (intraday, 1.65 and inter day, 1.38) and robust (% RSD was calculated to be 0.66, 0.58 and 0.81 for variation in mobile phase composition, wave length and flow velocity respectively) for the analysis of Cilnidipine. Conclusion: The developed method has passed all the validation tests and can be successfully applied to estimate the presence of Cilnidipine in bulk as well as in pharmaceutical formulations.

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Development and Validation of rp-HPLC Method of Cabozantinib in Active Pharmaceutical Ingredient and Pharmaceutical Dosage form

Cited by 5 publications

References 0 publications

Development, Validation, and Application of the UPLC-DAD Methodology for the Evaluation of the Qualitative and Quantitative Composition of Phenolic Compounds in the Fruit of American Cranberry (Vaccinium macrocarpon Aiton)

Development, Validation, and Application of the UPLC-DAD Methodology for the Evaluation of the Qualitative and Quantitative Composition of Phenolic Compounds in the Fruit of American Cranberry (Vaccinium macrocarpon Aiton)

Mechanism of Action, Synthesis, Properties and Analytical Methods of Cabozantinib

Development and Validation of Ultraviolet and Reverse Phase-high Performance Liquid Chromatographic Method for Estimation of Cilnidipine

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