Implementation of green analytical principles to develop and validate the HPLC method for the separation and identification of degradation products of Panobinostat, and its characterization by using LC-QTOF-MS/MS and its in-silico toxicity prediction using ADMET software

Bhukya, Vijay Nayak; Beda, Durga Prasad

doi:10.1016/j.greeac.2023.100090

Green Analytical Chemistry

2024

DOI: 10.1016/j.greeac.2023.100090

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Implementation of green analytical principles to develop and validate the HPLC method for the separation and identification of degradation products of Panobinostat, and its characterization by using LC-QTOF-MS/MS and its in-silico toxicity prediction using ADMET software

Vijay Nayak Bhukya,

Durga Prasad Beda

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2024

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Cited by 4 publications

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Stability indicating RP‐HPLC method development and validation for quantification of impurities in gonadotropin‐releasing hormone (Elagolix): Robustness study by quality by design

Bandaru,

Kanuparthy,

Jeedimalla

et al. 2024

Biomedical Chromatography

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The purpose of this research was to establish and validate a reverse phase HPLC method for the determination of Elagolix impurities in pharmaceutical dosage form. Mobile phase A, consisting of 10 mM sodium dihydrogen phosphate (pH 6.0) and acetonitrile in a 95:5 v/v ratio, and mobile phase B, containing 85:10:5 v/v/v of acetonitrile, Milli‐Q water, and methanol, were used to achieve the method's specificity in the analytical column Kromasil 100‐C18 (250 mm × 4.6 mm, 5 μm). The gradient program includes (%B/Time [min]: 36/0, 36/10, 38/15, 85/55, 85/65, 36/67, and 36/75). The flow rate is 0.8 mL/min. The overall run duration is 75.0 min, the injection volume is 10.0 μL, and the detection is at 210 nm in UV. The samples were subjected to hydrolysis, oxidation, and heat conditions in order to facilitate their forced degradation. The procedure was validated and determined with the standards of ICH guidelines. From the LOQ to a concentration level of 200%, the linearity of the technique was ascertained. An accuracy range of LOQ to 150% was established for the method, and the average recovery was acceptable. Design of experiments, part of the quality by design idea, was used to prove the method's reliability.

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Stability indicating RP‐HPLC method development and validation for quantification of impurities in gonadotropin‐releasing hormone (Elagolix): Robustness study by quality by design

Bandaru,

Kanuparthy,

Jeedimalla

et al. 2024

Biomedical Chromatography

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Green Analytical Approach for HPLC Method Development for Quantification of Sorafenib and Its Pharmacopeia Impurities: LC–MS/MS Characterization and Toxicity Prediction of Stress Degradation Products

Bhupatiraju,

Peddi,

Edla

et al. 2024

Separation Science Plus

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This research presents the development and validation of chromatographic method for analyzing sorafenib and its pharmacopeial impurities, with a focus on stability studies and degradation product (DP) characterization. Initial method optimization involved exploring various column and buffer combinations, ultimately achieving optimal separation and peak symmetry using an ODS‐AQ YMC (150 mm) column with 0.6 mL/min gradient flow of 10 mM ammonium formate buffer adjusted to pH 3.4 with formic acid as solvent A, and ethanol as solvent B as mobile phase and 246 nm wavelength. Method exhibits calibration curve linear in 50–300 µg/mL for sorafenib and 0.050–0.30 µg/mL for impurities with a detection limit of 0.015 µg/mL for impurities. A structural elucidation of DPs was performed using LC–MS/MS, providing valuable insights into their molecular compositions, and was characterized as 4‐[4‐(carboxyamino)phenoxy]pyridine‐2‐carboxylic acid (DP 1) and 4‐(4‐aminophenoxy)pyridine‐2‐carboxamide (DP 2). Using AGREE and GAPI metrics, evaluation highlighted method sustainability through ethanol–water solvents and shorter column to reduce energy consumption. Toxicity assessments revealed differences in environmental impact and toxicological profiles of DPs, emphasizing importance of managing safety considerations for sorafenib and its DPs. This research offers novel insights into sorafenib analysis by addressing pharmacopeial impurities, characterizing DPs, and evaluating method sustainability and safety.

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Combined green analytical principles and quality by design for ultraperformance liquid chromatography analytical method development, the characterization and in-silico toxicity prediction of Ixazomib degradation products using mass spectrometry

Bhukya,

Beda,

Gubbiyappa

et al. 2024

Green Analytical Chemistry

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Implementation of green analytical principles to develop and validate the HPLC method for the separation and identification of degradation products of Panobinostat, and its characterization by using LC-QTOF-MS/MS and its in-silico toxicity prediction using ADMET software

Cited by 4 publications

References 32 publications

Stability indicating RP‐HPLC method development and validation for quantification of impurities in gonadotropin‐releasing hormone (Elagolix): Robustness study by quality by design

Stability indicating RP‐HPLC method development and validation for quantification of impurities in gonadotropin‐releasing hormone (Elagolix): Robustness study by quality by design

Green Analytical Approach for HPLC Method Development for Quantification of Sorafenib and Its Pharmacopeia Impurities: LC–MS/MS Characterization and Toxicity Prediction of Stress Degradation Products

Combined green analytical principles and quality by design for ultraperformance liquid chromatography analytical method development, the characterization and in-silico toxicity prediction of Ixazomib degradation products using mass spectrometry

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