Development and validation of an ecofriendly HPLC-UV method for determination of capecitabine in human plasma: Application to pharmacokinetic studies

Hassanlou, Sepideh; Rajabi, Mehdi; Shahrasbi, Abdolali; Afshar, Minoo

doi:10.17159/0379-4350/2016/v69a21

Cited by 11 publications

(7 citation statements)

References 18 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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“…Green RP-HPLC methods using ethanol-based mobile phases have been widely reported for the analysis of drugs in pharmaceutical formulations [ 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 ], as well as in biological samples [ 55 , 56 ] ( Table 1 ). For example, a HPLC/diode-array detector (DAD) method using EtOH as the organic solvent in the mobile phase and an octadecyl-grafted silica column, was developed and validated by our team for the analysis of statins (i.e., pravastatin, fluvastatin, and atorvastatin in high concentrated EtOH/water solutions) [ 42 ].…”

Section: Alternative Organic Solvents In Rp-hplcmentioning

confidence: 99%

“…In the field of bioanalysis, there are also some articles dealing with the use of EtOH as a green organic modifier in the mobile phase for the chromatographic analysis of pharmaceutical compounds [ 55 , 56 ]. For example, a HPLC assay was developed and validated by Hassanlou et al [ 56 ] for the determination of capecitabine in human plasma using a C18 reversed-phase analytical column and a mobile phase composed of formic acid solution (pH 3):EtOH (55:45, v / v ).…”

Section: Alternative Organic Solvents In Rp-hplcmentioning

confidence: 99%

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

et al. 2018

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The greening of analytical methods has gained increasing interest in the field of pharmaceutical analysis to reduce environmental impacts and improve the health safety of analysts. Reversed-phase high-performance liquid chromatography (RP-HPLC) is the most widely used analytical technique involved in pharmaceutical drug development and manufacturing, such as the quality control of bulk drugs and pharmaceutical formulations, as well as the analysis of drugs in biological samples. However, RP-HPLC methods commonly use large amounts of organic solvents and generate high quantities of waste to be disposed, leading to some issues in terms of ecological impact and operator safety. In this context, greening HPLC methods is becoming highly desirable. One strategy to reduce the impact of hazardous solvents is to replace classically used organic solvents (i.e., acetonitrile and methanol) with greener ones. So far, ethanol has been the most often used alternative organic solvent. Others strategies have followed, such as the use of totally aqueous mobile phases, micellar liquid chromatography, and ionic liquids. These approaches have been well developed, as they do not require equipment investments and are rather economical. This review describes and critically discusses the recent advances in greening RP-HPLC methods dedicated to pharmaceutical analysis based on the use of alternative solvents.

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“…The aim of the present study was to further verify the implementation of the protein precipitation method using the antineoplastic agent capecitabine and its first metabolite, 5′-deoxy-5-fluorocytidine (5′-DFCR). In this work, the qualitative and quantitative composition of each biological specimen was accurately assessed using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection (Thorat, Chikhale, Tajne, 2019;Vijaya Jyothi et al, 2018;Hassanlou et al, 2016;Piórkowska et al, 2014;Komarov et al, 2014;Farkouh et al, 2010;Zufı á, Aldaz, Giráldez, 2004).…”

Section: Introductionmentioning

confidence: 99%

A small-scale method of sample preparation suitable for simultaneous HPLC-UV assay of capecitabine and its 5’-DFCR metabolite in mouse blood plasma

Kolev

Stoeva

Илиев

et al. 2022

Braz. J. Pharm. Sci.

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The objective of the study was to develop an easy, cheap, effective, and safe, small-scale method for sample preparation suitable for the simultaneous high-performance liquid chromatography (HPLC)-ultraviolet (UV) assay of capecitabine and its 5′-deoxy-5-fluorocytidine (5′-DFCR) metabolite in mouse blood plasma. The suitability of the proposed method of sample preparation was verified by the optimal effectiveness and efficiency achieved in the overall analytical workflow. The chromatographic separation of capecitabine and its first metabolite was performed on a Hypersil GOLD aQ column with a mobile phase consisting of 1% formic acid, methanol, and water, and run in a gradient elution mode. The absence of interfering endogenous components at the retention times of each analyte was confirmed by the chromatographic analysis of blank matrices and matrices spiked with the corresponding standards. The absence of any tactile matrix effect was also recorded. For the first time, the effect of the vacutainer's anticoagulant on the extraction efficiency of both analytes was evaluated. The method was found to be accurate, precise, and specific. The estimated mean "extraction" efficiencies were ≥90% for each analyte. The lower limit of quantitation for both capecitabine and 5′-DFCR was 0.05 μg/mL.

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Development and validation of an ecofriendly HPLC-UV method for determination of capecitabine in human plasma: Application to pharmacokinetic studies

Cited by 11 publications

References 18 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

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

A small-scale method of sample preparation suitable for simultaneous HPLC-UV assay of capecitabine and its 5’-DFCR metabolite in mouse blood plasma

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