Method development, degradation pathway and kinetic of capecitabine

Patel, Dhara R.

doi:10.18231/2394-2797.2018.0021

Cited by 2 publications

(2 citation statements)

References 3 publications

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“…Numbers of analytical methods such as RP-HPLC, LC-MS, UV-Visible spectrophotometric method, stability-indicating RP-HPLC methods have been reported for estimation of capecitabine [8][9][10][11][12][13][14][15][16][17][18][19][20] . But there was no stability-indicating UV-visible spectrophotometry method was found reported by which capecitabine can be estimated independently to degradation products formed in different stress conditions such as hydrolysis, photolysis, oxidation, dry heat degradation etc.…”

Section: Figure I: Chemical Structure Of Capecitabinementioning

confidence: 99%

Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

Prajapati¹,

Patel²,

Patel³

et al. 2020

AJPTR

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Capecitabine is an anti-metabolite class of anti-neoplastic drug that is converted to fluorouracil in body tissue. Numbers of stability indicating chromatography method such as HPLC, HPTLC etc.have been reported for stability study of capecitabine. But the chromatography methods are tedious, time and solvent consuming methods. Hence, stability-indicating UV-visible spectroscopy method has been developed for hydrolytic degradation kinetic study of capecitabine using design of experiments (DoE)-based enhanced quality by design approach (QbD) to save time, solvent and cost of analysis. The potential method parameters were identified and assessed by risk priority number (RPN) ranking and filtering. The DoE-based full factorial designs were applied for degradation kinetic study in alkaline and acidic medium at different temperature. The rate constant, order of reaction, half-life and % degradation of capecitabine was calculated. The absorbencies of all samples were measured at 307nm wavelength and linearity of capecitabine was found to be in the range of 5-25µg/mL. The order of reactions for alkaline and acidic degradation kinetic was found to be first order. The highest degradation rate constant and % degradation of capecitabine was found to be in 0.3 N acid or base at 50˚C. The prediction of rate constant and % degradation of capecitabine was done using DoE-based response surface analysis. The data of degradation kinetic was found to be in good agreement with published RP-HPLC method of capecitabine.

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Section: Figure I: Chemical Structure Of Capecitabinementioning

confidence: 99%

Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

Prajapati¹,

Patel²,

Patel³

et al. 2020

AJPTR

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“…Capecitabine is a fluoropyrimidine carbamate, antimetabolite class of antineoplastic drug 9 . QbD helps build the quality of products by design through risk assessment at the early stage and defining the design space later.…”

Section: Introductionmentioning

confidence: 99%

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2023

IJPSR

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A simple, specific, accurate, reliable, and precise reverse-phase highperformance liquid chromatographic method was developed by quality by design approach and validated for the estimation of Capecitabine in bulk and tablet dosage forms. A surface methodology was used to optimize the data with a three-level Box Behnken Design (BBD) was used. Mobile phase composition, flow rate, and column oven temperature were chosen as the three variables. The linearity was over the concentration range of 1-15 μg/ml with a correlation coefficient of 0.999. The LOD and LOQ were found to be 0.103 ug/mL and 0.313 ug/mL, respectively. Chromatographic separation was carried out by using a mobile phase of methanol: water (70:30 V/V) on Kromasil C18 column (250 mm X 4.6mm ID, 5 μm) in an isocratic mode at a flow rate of 0.9 ml/min with UV detection at 239 nm. The developed RP-HPLC method yielded a suitable retention time for Capecitabine of 4.70 min, which was optimized using the Design-Expert version 7.0.0. The percentage recovery was found to be 99.81%. The RSD percentage for methods precision was less than 2%. The developed methods were found to be precise and accurate for estimating Capecitabine in pharmaceutical dosage forms and could be used for routine analysis.

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Method development, degradation pathway and kinetic of capecitabine

Cited by 2 publications

References 3 publications

Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

Design of Experiments (DoE) - Based Enhanced Quality by Design Approach to Hydrolytic Degradation Kinetic Study of Capecitabine by Eco-friendly Stability Indicating UV-Visible Spectrophotometry

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