Development of novel univariate and multivariate validated chemometric methods for the analysis of dasatinib, sorafenib, and vandetanib in pure form, dosage forms and biological fluids

Attwa, Mohamed W.; Attia, Mohamed I.; Alanazi, Amer M.; AlRuqi, Obaid S.; AlRabiah, Haitham

doi:10.1016/j.saa.2021.120336

Cited by 8 publications

(3 citation statements)

References 45 publications

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“…Assays based on ion-pair associates [ 138 ] and 96-microwell-based spectrophotometric assay [ 139 , 140 ] have been reported for the convenient and accurate determination of TKIs in pharmaceutical formulations. However, traditional spectrophotometric methods may face challenges in distinguishing certain TKI structures (i.e., vandetanib, dasatinib, and sorafenib) due to their similar UV-visible characteristics [ 141 ]. For this reason, novel univariate [ 142 ] and multivariate validated chemometric methods [ 143 ] have been developed to simultaneously estimate TKIs in a mixture without the need for separation.…”

Section: Methodsmentioning

confidence: 99%

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

Chen,

Zhang,

Zhang

et al. 2024

Journal of Pharmaceutical Analysis

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Section: Methodsmentioning

confidence: 99%

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

Chen,

Zhang,

Zhang

et al. 2024

Journal of Pharmaceutical Analysis

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“…On the other hand, SOR was determined alone and in combinations with other drugs from biomatrices by spectrophotometric method [17], thin-layer chromatography (TLC) [18], HPLC methods [19,20] and LCMS/MS methods [21,22].…”

Section: Introductionmentioning

confidence: 99%

FDA-Validated Ecofriendly Chromatographic Methods for Simultaneous Determination of Gemcitabine and Sorafenib: Applications to Pharmacokinetics

et al. 2022

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Combination therapy of gemcitabine and sorafenib is synergistically effective and well tolerated in patients with non-small cell lung cancer (NSCLC). In this study, the pharmacokinetic parameters of both gemcitabine and sorafenib were estimated after intra-peritoneal administration in rats using novel, green and sensitive RP-HPLC and TLC-densitometric methods where sildenafil used as an internal standard. Firstly, the developed RP-HPLC method achieved on ZORBAX Eclipse Plus C18 (4.6 mm × 150 mm, 5 μm) using a mixture of methanol: 40 mM ammonium acetate solution. On the other hand, the developed TLC-densitometric method was achieved on TLC plates using a developing system of methanol: ethyl acetate (3: 7, by volume) and scanning wave length at 260 nm. Additionally, the developed methods were validated according to FDA guidelines. Moreover, the developed methods were successfully used to study the pharmacokinetic parameters of both gemcitabine and sorafenib after administration of each drug alone and co-administration in rats. The results presented that drug–drug interaction between drugs happened when administrated together affecting the pharmacokinetic parameters of each other. The proposed methods, being ecofriendly, accurate, and sensitive, may become the corner stone for further clinical studies of the studied drugs determinations applied on humans.

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“…Vandetanib (Caprelsa ® , Figure 1), or N-(4-bromo-2-fluorophenyl)-6-methoxy-7-((1methylpiperidin-4yl) methoxy) quinazolin-4-amine [1,2], was developed by AstraZeneca, who later sold the rights to Sanofi in 2015, and is a unique tyrosine kinase inhibitors (TKIs) used in the treatment of aggressive and symptomatic medullary carcinoma in thyroid glands. It acts through the inhibition of various receptors of human cells, such as the epidermal growth factor receptor, RET-tyrosine kinase and others [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

A Novel Green Micellar HPLC-UV Method for the Estimation of Vandetanib in Pure Form, Human Urine, Human Plasma and Human Liver Microsomes Matrices with Application to Metabolic Stability Evaluation

2022

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Vandetanib (Caprelsa®; VNB) is a prescription medicine that is used for the treatment of medullary thyroid cancer that has disrupted other body parts or that cannot be removed by surgery. It is considered a tyrosine kinase inhibitor (TKI). Fast, sensitive and validated HPLC–UV was established for VNB quantification in pure human biological fluids (urine and plasma) and human liver microsomes (HLMs). This analytical methodology was applied also to the metabolic stability assessment of VNB. This method was performed using a phenyl column (250 mm × 4.6 mm id, 5 µm particle size). A sodium dodecyl sulphate solution (0.05 M, pH 3.0 using 0.02 M orthophosphoric acid) containing 0.3% triethylamine and 10% n-butanol was used as a mobile phase and was pumped isocratically at a flow rate of 0.7 mL/min and at a 260 nm detection wavelength. The total elution time was 6 min with an injection volume of 20 μL. The linearity of the established methodology ranged from 30 to 500 ng/mL in pure form and 50 to 500 ng/mL (r2 ≥ 0.9994) in human biological fluids and HLMs. No significant interference from the matrix components was observed. The proposed methodology revealed the benefits of being green, reliable and economic.

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Development of novel univariate and multivariate validated chemometric methods for the analysis of dasatinib, sorafenib, and vandetanib in pure form, dosage forms and biological fluids

Cited by 8 publications

References 45 publications

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

FDA-Validated Ecofriendly Chromatographic Methods for Simultaneous Determination of Gemcitabine and Sorafenib: Applications to Pharmacokinetics

A Novel Green Micellar HPLC-UV Method for the Estimation of Vandetanib in Pure Form, Human Urine, Human Plasma and Human Liver Microsomes Matrices with Application to Metabolic Stability Evaluation

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