Development and Validation of a Superior High Performance Liquid Chromatographic Method for Quantification of Axitinib in Solid Oral Dosage Form

Panda, Sagar Suman; Bera, Venkata Varaha Ravi Kumar; Panda, Niranjan

doi:10.7726/ajmc.2016.1003

Cited by 3 publications

(1 citation statement)

References 2 publications

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“…It is used in the treatment of advanced renal cell Carcinoma by acting as tyrosine kinase receptors VEGFR-1 (vascular endothelial growth factor receptor), VEGFR-2, and VEGFR-3 blocker [1][2][3]. According to the literature survey, very few methods were developed using HPLC [4][5][6]only. As no UPLC method was developed, the proposed method aimed to develop and validate a stability indicating method for the estimation of Axitinib in pharmaceutical dosage form using UPLC.…”

Section: Axitinib (Fig1) Chemically Designated As N-methyl-2-[[3-mentioning

confidence: 99%

Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

Godavarthi¹,

Mondal²

2017

IJPBR

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A Stability Indicating Ultra-Performance Liquid Chromatography method was developed and validated for quantification of Axitinib in tablets. The chromatographic separation was done in an isocratic mode using the STD RP-18 Endcapped (50mm × 4.6mm, 2µ particle size) column. The mobile phase 0.1% OPA and acetonitrile 55:45 (%v/v) at the flow rate of 0.2mL/min and at ambient temperature was used. The wavelength used for detection was 249nm. The retention time for Axitinib was found to 1.03min. Axitinib was linear in the concentration range of 12.5µg/mL to 75µg/mL respectively. The developed method was validated and found to be accurate, specific and robust. The drug was subjected to the stressed conditions like acidic, basic, oxidative, photolytic, thermal and neutral conditions. The degradation results are found satisfactory. This method can be applied for the estimation of Axitinib in pharmaceutical dosage forms.

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Section: Axitinib (Fig1) Chemically Designated As N-methyl-2-[[3-mentioning

confidence: 99%

Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

Godavarthi¹,

Mondal²

2017

IJPBR

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Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets

Chalikwar¹,

Kayande²,

Singh³

et al. 2018

JPTRM

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Axitinib is a tyrosine kinase Inhibiter. In a commenced analysis, a effortless and responsive high-performance liquid-chromatography method was developed and validated for the quantitative estimation of Axitinib in bulk and in-house tablet dosage form. The present method was developed and validated using LC-GC Qualisil BDS C18 (250 mm × 4.6 mm, 5 μm). The separation of Axitinib was employed using a methanol: water 85:15% v/vas a mobile phase at optimal flow rate 1 mL/min and column oven temperature 30°C. While, Axitinib was examined at 330 nm with a photo diode array detector; retention timewas found to be 3.23 min.The intended method was validated by ICH rules for the accuracy, precision, sensitivity, and ruggedness. The linearity was followed in the concentration range of 4 - 24 μg/ mL as demonstrated by correlation coefficient (r2) of 0.9994. The robustness of proposed method was assessed by purposelyvarying the chromatographic conditions. Consequently, the intended method can routinely be subjected for th estimation of Axitinib in bulk and in tablets formulation.

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ICH/FDA Guidelines-Compliant Validated Stability-Indicating HPLC-UV Method for the Determination of Axitinib in Bulk and Dosage Forms

Darwish

Khalil

AlZeer

2020

CAC

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Background: Axitinib (AXT) is a member of the new generation of the kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. Its therapeutic benefits depend on assuring the good-quality of its dosage forms in terms of content and stability of the pharmaceutical active ingredient. Objective: This study was devoted to the development of a simple, sensitive and accurate stability-indicating highperformance liquid chromatographic method with ultraviolet detection (HPLC-UV) for determination of AXT in its bulk and dosage forms. Methods: Waters HPLC system was used. The chromatographic separation of AXT, internal standard (olaparib), and degradation products were performed on Nucleosil CN column (250  4.6 mm, 5 µm ). The mobile phase consisted of water:acetonitrile:methanol (40:40:20, v/v/v) with a flow rate of 1 ml/min, and the UV detector was set at 225 nm. AXT was subjected to different accelerated stress conditions and the degradation products, when any, were completely resolved from the intact AXT. Results: The method was linear (r = 0.9998) in the concentration range of 5 - 50 μg/ml. The limits of detection and quantitation were 0.85 and 2.57 μg/ml, respectively. The accuracy of the method, measured as recovery, was in the range of 98.0 - 103.6% with relative standard deviations in the range of 0.06 - 3.43%. The results of stability testing revealed that AXT was mostly stable in neutral and oxidative conditions; however, it was unstable in alkaline and acidic conditions. The kinetics of degradation were studied, and the kinetic rate constants were determined. The proposed method was successfully applied for the determination of AXT in bulk drug and dosage form. Conclusions: A stability-indicating HPLC-UV method was developed and validated for assessing AXT stability in its bulk and dosage form. The method met the regulatory requirements of the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA). The results demonstrated that the method would have a great value when applied in quality control and stability studies for AXT.

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Development and Validation of a Superior High Performance Liquid Chromatographic Method for Quantification of Axitinib in Solid Oral Dosage Form

Cited by 3 publications

References 2 publications

Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

Development and Validation of Stability indicating method for the estimation of Axitinib in tablet dosage forms by UPLC

Exploring RP-HPLC Method for analysis of Axitinib in Bulk and in-house Tablets

ICH/FDA Guidelines-Compliant Validated Stability-Indicating HPLC-UV Method for the Determination of Axitinib in Bulk and Dosage Forms

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