Characterization and toxicity evaluation of degradation products of febantel

Mahajan, Anand A.; Marathe, A. M.; Jarande, Suvarna S.; Pissurlenkar, Raghuvir R. S.; Gawande, Vandana

doi:10.1186/s43094-020-00138-7

Cited by 3 publications

(3 citation statements)

References 23 publications

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“…For example: In following figure 6 showing separation of febantel and its degradation products. 69 Step V: Final method development and optimization After preliminary separation studies,a mixture of the reaction solutions is prepared,and subjected again to resolution behavior study. While making this mixture, it is not always necessary to add all reaction solutions withdrawn at different time for all conditions.…”

Section: Fig 3 Techniques Used In Stability Indicating Methodsmentioning

confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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This article provides an overview on Development and Validation of Force degradation study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions (hydrolysis, oxidation, thermal, and photolytic conditions) are applied to drugs compounds during a process known as forced degradation, and as a result, various degradation products are created. The major purpose of these investigations is to assess a molecule's stability under accelerated settings. It is well recognized that the stability of molecules affects the regulatory documentation process, the choice of appropriate storage and packaging conditions, and the choice of formulation. The deficiencies of reported methods in terms of regulatory requirements are highlighted. This article is to provide appropriate International conference of harmonization (ICH) criteria for force degradation study and to discuss the methodical process for creating verified SIAMs. The aspects of Mass balance in SIMs are discussed and technique used in SIMs were highlighted. Recent advance in stability indicating methods include characterization of degrdant sample and in-vitro toxicity prediction are addressed. Background of force degradation study with stability indicating methods with respect to international author and national author are discussed.

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Section: Fig 3 Techniques Used In Stability Indicating Methodsmentioning

confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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“…18 Such impurities are called degradation products and usually determined the degradation pathway through stability tests and forced degradation tests. 19 The forced degradation test is that the drug is destroyed by high temperature, high humidity, strong light irradiation, acid hydrolysis, alkali hydrolysis and oxidation, 20 which can obtain a large amount of impurity information in a short time and provide guidance for the packaging and storage conditions of drugs to avoid and reduce the generation of drug degradation products. Some elemental impurities are introduced when the catalysts or reagents added intentionally during the synthesis of drugs.…”

Section: Sources Of Impurities In Synthetic Drugsmentioning

confidence: 99%

Research progress on the impurities identification and determination in pharmaceuticals

Chen

Zhang

et al. 2023

Preprint

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Rationale: Impurities refer to any substances that affect the purity of pharmaceuticals. Controlling impurities has always been a significant concern during drug development. Impurities impact the drug’s purity, diminish the efficacy of pharmaceuticals, and alter their appearance, physical, and chemical properties. Additionally, impurities can compromise the stability of pharmaceuticals and elevate their toxic and side effects. Methods: Impurity source analysis is the basis of drug impurity control. To clarify the source of impurity can optimize the synthesis process, prescription process, packaging and storage conditions of the pharmaceuticals, and control the impurity within a reasonable limit to achieve the ultimate goal of impurity research. Results: Analysis method is a means to obtain impurity information, and diversified analysis methods are also possible for effective control of different types of impurities. At present, there are relatively many quantitative studies on impurities, but there are still some challenges for the structure analysis of impurities, especially trace impurities. Conclusion: The research progress of drug impurity control and evaluation from the sources of various drug impurities and impurity analysis techniques was reviewed in this article, with the aim of providing references for the related research.

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“…specific parent ion and specific daughter ions that match the mass of the target molecule are isolated within the mass spectrometer. The experiment becomes more sensitive while preserving the highest level of accuracy by disregarding any other ions that enter the mass spectrometer [ 51 – 57 ].…”

Section: Introductionmentioning

confidence: 99%

Sustainable chromatographic quantitation of multi-antihypertensive medications: application on diverse combinations containing hydrochlorothiazide along with LC–MS/MS profiling of potential impurities: greenness and whiteness evaluation

Marzouk,

El-Hanboushy,

Obaydo

et al. 2023

BMC Chemistry

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Cardiovascular disorders are among the leading causes of death worldwide, especially hypertension, a silent killer syndrome requiring multiple drug therapy for appropriate management. Hydrochlorothiazide is an extensively utilized thiazide diuretic that combines with several antihypertensive drugs for effective treatment of hypertension. In this study, sustainable, innovative and accurate high performance liquid chromatographic methods with diode array and tandem mass detectors (HPLC–DAD and LC–MS/MS) were developed, optimized and validated for the concurrent determination of Hydrochlorothiazide (HCT) along with five antihypertensive drugs, namely; Valsartan (VAL), Amlodipine besylate (AML), Atenolol (ATN), Amiloride hydrochloride (AMI), and Candesartan cilextil (CAN) in their diverse pharmaceutical dosage forms and in the presence of Chlorothiazide (CT) and Salamide (DSA) as HCT officially identified impurities. The HPLC–DAD separation was achieved utilizing Inertsil ODS-3 C18 column (250 × 4.6 mm, 5 μm) attached with photodiode array detection at 225.0 nm. Gradient elution was performed utilizing a mixture of solvent A (20.0 mM potassium dihydrogen phosphate, pH 3.0 ± 0.2, adjusted with phosphoric acid) and solvent B (acetonitrile) at ambient temperature. Linearity ranges were 0.1–100.0 µg/mL for HCT, VAL, AML and CAN, 0.05 –100.0 µg/mL for both ATN and AMI and 0.05–8.0 µg/mL for both CT and DSA. Additionally, this work describes the use of liquid chromatography–electrospray–tandem mass spectrometry for the accurate detection and quantification of the impurities; CT and DSA in the negative mode utilizing triple quadrupole mass spectrometry. The linearity ranges for those impurities were 1.0–200.0 ng/mL and 5.0–200.0 ng/mL for CT and DSA, respectively. Developed methods’ validation was achieved in accordance with International Conference on Harmonization (ICH) guidelines. Upon applying liquid chromatographic techniques for the drug analysis, a green and sustainable assessment have to be handled due to the consumption of energy and many solvents. Through the use of the HEXAGON, Analytical Greenness (AGREE) and White Analytical Chemistry (WAC) tools, greenness and sustainability have been statistically assessed. The optimized HPLC–DAD and LC–MS/MS methods were fast, accurate, precise, and sensitive, and consequently could be applied for conventional analysis and quality control of the proposed drugs in their miscellaneous dosage forms for the purpose of reducing laboratory wastes, time of the analysis time, effort, and cost. Graphical Abstract

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Characterization and toxicity evaluation of degradation products of febantel

Cited by 3 publications

References 23 publications

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Research progress on the impurities identification and determination in pharmaceuticals

Sustainable chromatographic quantitation of multi-antihypertensive medications: application on diverse combinations containing hydrochlorothiazide along with LC–MS/MS profiling of potential impurities: greenness and whiteness evaluation

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