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

Chalikwar, Shailesh S.; Kayande, Satish D.; Singh, Inderbir; Shirkhedkar, Atul A.

doi:10.15415/jptrm.2018.62010

Cited by 3 publications

(1 citation statement)

References 7 publications

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“…However, it is not listed in the Indian Pharmacopoeia 2018 or the United States Pharmacopoeia (USP) National Formulary 2019. Despite its analysis using various methods, such as ultraviolet spectrophotometry [3,4], ultra-performance liquid chromatography [5], reversed-phase high-performance liquid chromatography [6][7][8][9][10][11][12], liquid chromatographymass spectrometry (LC-MS) [13], and LC-MS/MS [14], both singly and in combination with other drugs, no high-performance thin-layer chromatography (HPTLC) method has been reported for Axitinib assessment in tablet formulations.…”

Section: Introductionmentioning

confidence: 99%

Analytical quality by design‐based thin‐layer chromatography method development and validation for assay and content uniformity testing of the anti‐neoplastic drug Axitinib in tablet formulation

Koradia,

Patel,

Sen

et al. 2023

Separation Science Plus

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The current study aims to develop and validate an analytical quality by design approach‐based high‐performance thin‐layer chromatographic (HPTLC) method for the analysis of Axitinib tablet samples. The chromatographic conditions in the TLC method were optimized using a three‐level full factorial design. The mobile phase composition and chamber saturation time served as the independent variables for optimization. The mobile phase used for TLC separation on pre‐coated aluminum plates with silica gel 60 F254 consisted of a mixture of ethyl acetate and isopropyl alcohol in a ratio of 9:1 (v/v). Axitinib was quantified at 330 nm using the densitometric method. Axitinib peak from tablet formulation was verified against the reference standard by comparing its single band at Rf 0.44 ± 0.02. Linearity was found to exist between 100 and 600 ng/band, with a correlation coefficient (r2) of 0.9978. The percentage recovery was obtained as 98.21%–99.05%. The system was validated by determining the parameters according to the guidelines of the International Council for Harmonization of Technical Conditions for Medical Products for Human Use. The proposed TLC method can be effectively applied to routine quality control of a pharmaceutical product.

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Section: Introductionmentioning

confidence: 99%

Analytical quality by design‐based thin‐layer chromatography method development and validation for assay and content uniformity testing of the anti‐neoplastic drug Axitinib in tablet formulation

Koradia,

Patel,

Sen

et al. 2023

Separation Science Plus

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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 HPLC Method Along With Anti-Aging Activity for Ximenynic Acid in Santalum Album Linn.

Shivatare¹,

Jangra²,

Gaikwad³

et al. 2023

IND. DRU.

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A new analytical approach and validation study were developed to assess the quantity of ximenynic acid (XMA) in Santalum album Linn. extract. High-performance liquid chromatography (HPLC) in reverse phase is the technique that is used in this procedure. The anti-aging properties of the medicine were tested using enzymes that inhibit hyaluronidase and elastase, respectively, in order to gather information and findings. Methanol and water were used as the mobile phase for the analysis, which was carried out using a ZORBAX SB-C18 column with a size 5 µ (4.6 x 250 mm) column size. During the course of this HPLC method validation, a number of different tests that were pertinent to specificity, linearity, accuracy, precision and robustness were carried out. The technique was tested to see whether or not it would be able to fulfill the prerequisites set out by the International Conference on Harmonization (ICH). Research conducted on anti-aging found that XMA was much more efficient than catechin at decreasing the activities of elastase and hyaluronidase. Because of its use, speed and reliability, the HPLC method that was described has the potential to be effectively utilized in industry for the standardization of herbs and phytomedicines. Because XMA has the potential to be a breakthrough anti-aging treatment, the pharmaceutical and cosmetics industries may benefit from its development.

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

Cited by 3 publications

References 7 publications

Analytical quality by design‐based thin‐layer chromatography method development and validation for assay and content uniformity testing of the anti‐neoplastic drug Axitinib in tablet formulation

Analytical quality by design‐based thin‐layer chromatography method development and validation for assay and content uniformity testing of the anti‐neoplastic drug Axitinib in tablet formulation

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

Development and Validation of HPLC Method Along With Anti-Aging Activity for Ximenynic Acid in Santalum Album Linn.

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