A Model Approach for Developing Stability-Indicating Analytical Methods

Persich, Peter; Hellings, Mario; Jhajra, Shalu; Phalke, Pradeep; Vanhoutte, Koen

doi:10.1007/978-1-4939-7686-7_5

Cited by 3 publications

(6 citation statements)

References 5 publications

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“…Furthermore, the stability-indicating analytical method should be able to detect drug substance quality attributes changes during storage. 9,10 In May 2022, the adoption of a new guideline covering AQbD topics by the International Council for Harmonization (ICH)−Q14 is expected. Therefore, the AQbD process is already being implemented in the pharmaceutical industry 11−15 and is actively pursued in our laboratories.…”

Section: Introductionmentioning

confidence: 99%

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Development of an Analytical Method for Determination of Related Substances and Degradation Products of Cabotegravir Using Analytical Quality by Design Principles

et al. 2022

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Cabotegravir is one of the newly approved human immunodeficiency virus (HIV) integrase enzyme inhibitors used for the prevention and treatment of HIV infection. It is the first approved long-acting injectable antiretroviral therapy for HIV and is also very effective in combination with rilpivirine, a nonnucleoside reverse transcriptase inhibitor. Therefore, future drug development involving cabotegravir can be expected. We developed an ultrahigh performance liquid chromatography (UHPLC) method compatible with mass spectrometry for the determination of eight cabotegravir impurities. The described method is able to differentiate cabotegravir and its related substances as well as its degradation products. Analytical quality by design principles were used for method development. The method is robust within the defined method operable design region: flow rate = 0.32−0.40 mL/min; column temperature = 30−40 °C; pH of mobile phase A = 3.25−3.75, and the final percent of acetonitrile in gradient = 50.0−60.0%. Inside the method operable design region, a working optimal point was selected: pump flow rate = 0.36 mL/min; column temperature = 35 °C; pH of mobile phase A = 3.5, and final percent of acetonitrile in gradient = 55%. Method validation was performed, and the following parameters were verified: accuracy, repeatability, linearity, response factors, detection limit, and quantification limit. All method validation results were within selected criteria. The presented method could be used for the development of new pharmaceutical products based on cabotegravir.

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Section: Introductionmentioning

confidence: 99%

“…The developed liquid chromatography method should be able to discriminate between cabotegravir and its related substances as well as its degradation products. Furthermore, the stability-indicating analytical method should be able to detect drug substance quality attributes changes during storage. , …”

Section: Introductionmentioning

confidence: 99%

Development of an Analytical Method for Determination of Related Substances and Degradation Products of Cabotegravir Using Analytical Quality by Design Principles

et al. 2022

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“…9 Most importantly, a stability-indicating liquid chromatography (LC) method should be capable of discriminating between the active pharmaceutical ingredient and its degradation products. 10 − 14 …”

Section: Introductionmentioning

confidence: 99%

“…A stability-indicating test should be able to detect changes in quality attributes during storage . Most importantly, a stability-indicating liquid chromatography (LC) method should be capable of discriminating between the active pharmaceutical ingredient and its degradation products. − …”

Section: Introductionmentioning

confidence: 99%

Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles

Žigart

Časar

2020

ACS Omega

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Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax. No analytical method for the determination of venetoclax can currently be found in the literature. We developed a mass spectrometry-compatible stability-indicating ultrahigh-performance liquid chromatography (LC) method for venetoclax. The LC method was developed using analytical quality by design principles. The developed method is able to separate venetoclax and its degradation products. The method was validated in the working point where a linearity range was established and accuracy, repeatability, and selectivity were assessed. Venetoclax is the only Bcl-2 protein inhibitor on the market. It is very effective in combinational therapy, so future drug development involving venetoclax may be expected. A stability-indicating method could aid in the development of new pharmaceutical products with venetoclax.

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“…A Entre as técnicas utilizadas para o desenvolvimento dos MIE, podem-se citar a cromatografia líquida de alta eficiência (HPLC), cromatografia em camada delgada (CCD), cromatografia gasosa (CG), eletroforese capilar (CE). Quanto aos produtos de degradação, se não podem ser isolados de forma pura, devem ser utilizadas técnicas hifenadas, como a cromatografia líquida de alta eficiência acoplada à espectrometria de massas (HPLC-MS), a cromatografia líquida de alta eficiência acoplada com ressonância magnética nuclear (HPLC-RMN) ou cromatografia gasosa acoplada à espectrometria de massas (CG-MS) (QUADRI et al, 2014;PERSICH et al, 2018). Os métodos de cromatografia líquida de alta eficiência de fase reversa (HPLC-RF) são PORTER; ZHANG, 2017).…”

Section: Métodos Indicativos De Estabilidadeunclassified

Aplicação da eletroforese capilar - espectrometria de massas para identificação dos produtos de degradação do aripiprazol em medicamentos

Fajardo¹

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A Model Approach for Developing Stability-Indicating Analytical Methods

Cited by 3 publications

References 5 publications

Development of an Analytical Method for Determination of Related Substances and Degradation Products of Cabotegravir Using Analytical Quality by Design Principles

Development of an Analytical Method for Determination of Related Substances and Degradation Products of Cabotegravir Using Analytical Quality by Design Principles

Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles

Aplicação da eletroforese capilar - espectrometria de massas para identificação dos produtos de degradação do aripiprazol em medicamentos

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