Quantitative Estimation of Sorafenib Tosylate Its Pure Form and in Its Tablet Formulation by RP‐HPLC Method

Kalaichelvi, R.; Jayachandran, E.

doi:10.1155/2013/539264

Cited by 10 publications

(5 citation statements)

References 3 publications

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“…Thus, factors like mobile phase ratio and flow rate were finally selected as the CMPs for subsequent optimization studies. It was observed during the screening studies that the selectivity of the method for the drug was higher at acidic pH (Venkata Rao, Ramu, Biksham, Neeharika, & Rambabu, ) and at higher column temperature (Kalaichelvi & Jayachandran, ). Thus, the pH of the mobile phase was adjusted to 4.1 using orthophosphoric acid and formic acid as the pH modifiers during HPLC and LC‐MS studies, respectively, while the column temperature was fixed at 40°C.…”

Section: Resultsmentioning

confidence: 99%

“…Several attempts have already been reported in the literature at the liquid chromatographic analysis of SFN using RP‐HPLC (Kalaichelvi & Jayachandran, ), High‐performance thin‐layer chromatography (HPTLC) (Shivaji & Pramila, ) and liquid chromatography tandem mass spectroscopy (Li et al, ), mostly employing buffers in mobile phase composition. The buffer salts, in this regard, are documented to exhibit a tendency to block the column(s) (http://www.nestgrp.com/pdf/colcare).…”

Section: Introductionmentioning

confidence: 99%

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Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Sharma

Khurana

Jain

et al. 2018

Biomedical Chromatography

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The current research work envisages an analytical quality by design-enabled development of a simple, rapid, sensitive, specific, robust and cost-effective stability-indicating reversed-phase high-performance liquid chromatographic method for determining stress-induced forced-degradation products of sorafenib tosylate (SFN). An Ishikawa fishbone diagram was constructed to embark upon analytical target profile and critical analytical attributes, i.e. peak area, theoretical plates, retention time and peak tailing. Factor screening using Taguchi orthogonal arrays and quality risk assessment studies carried out using failure mode effect analysis aided the selection of critical method parameters, i.e. mobile phase ratio and flow rate potentially affecting the chosen critical analytical attributes. Systematic optimization using response surface methodology of the chosen critical method parameters was carried out employing a two-factor-three-level-13-run, face-centered cubic design. A method operable design region was earmarked providing optimum method performance using numerical and graphical optimization. The optimum method employed a mobile phase composition consisting of acetonitrile and water (containing orthophosphoric acid, pH 4.1) at 65:35 v/v at a flow rate of 0.8 mL/min with UV detection at 265 nm using a C column. Response surface methodology validation studies confirmed good efficiency and sensitivity of the developed method for analysis of SFN in mobile phase as well as in human plasma matrix. The forced degradation studies were conducted under different recommended stress conditions as per ICH Q1A (R2). Mass spectroscopy studies showed that SFN degrades in strongly acidic, alkaline and oxidative hydrolytic conditions at elevated temperature, while the drug was per se found to be photostable. Oxidative hydrolysis using 30% H O showed maximum degradation with products at retention times of 3.35, 3.65, 4.20 and 5.67 min. The absence of any significant change in the retention time of SFN and degradation products, formed under different stress conditions, ratified selectivity and specificity of the systematically developed method.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Sharma

Khurana

Jain

et al. 2018

Biomedical Chromatography

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“…The method was validated by linearity, precision, accuracy, LOD, and LOQ. The accuracy report denotes that there is not any interference of additives used in the formulation 7 .…”

Section: Hplc Methodsmentioning

confidence: 99%

Analytical estimation methods for determination of sorafenib

Thangabalan¹,

Kuruba²,

Goswami³

et al. 2022

World J. Bio. Pharm. Health Sci.

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Sorafenib is an anticancer drug is used to treat late stage kidney and liver cancer. Sorafenib is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the kidneys). Sorafenib is also used to treat hepatocellular carcinoma (a type of liver cancer) that cannot be treated with surgery and a certain type of thyroid cancer that has spread to other parts of the body and cannot be treated with radioactive iodine. Sorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. There are many reported analytical methods for estimation of Sorafenib. The present work list outs the various analytical methods for the estimation of the drug.

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“…The linearity was 10-50 µg/mL. Kalaichelvi R et al, 43 proposed a method for estimation of sorafenib tosylate in its pure form and in its tablet formulation by RP-HPLC method.…”

Section: Fig 2: Mechanism Of Tyrosine Kinase Inhibitorsmentioning

confidence: 99%

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2022

IJPSR

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Tyrosine kinase inhibitors generally having a narrow therapeutic window and large inter-patient variability. In order to support its therapeutic drug monitoring, fast and accurate methods are needed to supporting the pharmacokinetic-guided dosing in patients treating with various tyrosine kinase inhibitors (TKIs) either alone or in combination in bulk, formulations or human plasma using HPLC and detection with tandem mass spectrometry (HPLC-MS/MS), gas chromatography with mass spectrometry, spectrofluorimetry and UV-Visible spectrometry. Literature suggested that the methods developed and validated are good for accuracy, precision, and assay for all TKIs studied. These methods are also applied for routine therapeutic drug monitoring and investigator-initiated research. In this review, we described different analytical methods used for the qualitative and quantitative estimation of all TKIs investigated till 2020 in assessing the quality of drugs by using HPLC, LC-MS, HPTLC, UPLC, UV-Visible spectrophotometry, spectrofluorimetry with a huge survey from the research articles published in various pharmaceutical and analytical chemistry journals. From this assessment, these methods were found to be superior based on the quantitative analysis of drugs in API, formulations, biological fluids such as serum and plasma. Detailed validation parameters are also given for the methods that help the researchers select suitable analytical techniques based on the information sought.

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Quantitative Estimation of Sorafenib Tosylate Its Pure Form and in Its Tablet Formulation by RP‐HPLC Method

Cited by 10 publications

References 3 publications

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress‐induced degradation products and in biological matrix employing analytical quality by design approach

Analytical estimation methods for determination of sorafenib

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