Quality by design approach for enantioseparation of terbutaline and its sulfate conjugate metabolite for bioanalytical application using supercritical fluid chromatography

Aboushady, Dina; Hanafi, Rasha S.; Parr, Maria Kristina

doi:10.1016/j.chroma.2022.463285

Cited by 8 publications

(6 citation statements)

References 32 publications

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“…Hayes et al built a microscale SFC-based purification platform via the alteration of fluid channel and introduction of gas–liquid separators for the discovery and analysis of pharmaceuticals on ChiralPak Column (Westchester). More drug racemates of β2-agonist of terbutaline, β-blockers, antidepressant drug of paroxetine hydrochloride, and borneol lipid (candidate drug for cerebrovascular disease) were also efficiently resolved by SFC. − The coupling of different chiral columns can provide great opportunity to increase the separation efficiency of SFC . A two-dimensional chiral SFC based on two different CSPs of amylose tri-(3,5-dimethylphenylcarbamate) and cellulose tris (4-methyl-benzoate) was applied to chiral separation of aliphatic acid derivatives …”

Section: Chromatographymentioning

confidence: 99%

Recent Advances in Separation and Analysis of Chiral Compounds

Yan

2023

Anal. Chem.

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Section: Chromatographymentioning

confidence: 99%

Recent Advances in Separation and Analysis of Chiral Compounds

Yan

2023

Anal. Chem.

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“…A variety of analytical methods for medicinal plants have been developed through an AQbD approach, such as the mass spectrometry analysis [ 84 , 85 ], capillary electrophoresis analysis [ 86 , 87 , 88 ], supercritical fluid chromatography analysis [ 89 , 90 ], gas chromatography analysis [ 91 , 92 ] and so on. Applications of AQbD to the development a HPLC analysis were announced in many studies [ 36 , 37 , 38 , 39 , 40 , 48 , 49 ].…”

Section: Perspectives : Challenges and Prospectsmentioning

confidence: 99%

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Park

Kim

et al. 2022

Plants

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Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method operable design region (MODR), and lowers the out-of-specification (OOS) results. However, it is difficult to follow all the AQbD workflow steps in the field of medicinal plants analysis, such as defining the analytical target profiles (ATPs), identifying critical analytical procedure parameters (CAPPs), among others, because the complexity of chemical and biological properties in medicinal plants acts as a barrier. In this review, various applications of AQbD to medicinal plant analytical procedures are discussed. Unlike the analysis of a single compound, medicinal plant analysis is characterized by analyzing multiple components contained in biological materials, so it will be summarized by focusing on the following points: Analytical methods showing correlations within analysis parameters for the specific medicinal plant analysis, plant raw material diversity, one or more analysis targets defined for multiple phytochemicals, key analysis attributes, and analysis control strategies. In addition, the opportunities available through the use of design-based quality management techniques and the challenges that coexist are also discussed.

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“…The design of SFC‐MS interfaces has been improved over the years and, with advances in column technology, especially sub‐2 μm particle size ultra‐high performance columns, SFC‐MS technology has proven to be a good analytical tool 11,12 . There are examples of employing SFC‐MS for the analysis of pesticides, pharmaceuticals, metabolites and metabolomic studies 13–20 …”

Section: Introductionmentioning

confidence: 99%

Routine application of SFC‐MS in doping control: Analysis of 3 × 1000 urine samples using three different SFC‐MS instruments

Gavrilović,

Wüst,

Danaceau

et al. 2024

Drug Testing and Analysis

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Supercritical fluid chromatography‐mass spectrometry (SFC‐MS) has proved to be a beneficial tool for sample analysis for a wide variety of compounds and, as such, has recently gained the attention of the anti‐doping community. We have tested the applicability of SFC‐MS for routine doping control analysing approximately 3 × 1000 identical anti‐doping samples utilising SFC‐MS instruments from three different vendors: Agilent Technologies, Waters Corporation and Shimadzu Corporation. A ‘dilute and inject’ approach either without or after hydrolysis of glucuronide metabolites was applied. Most of the compounds included in our study demonstrated excellent chromatography, whereas some showed co‐elution with endogenous interferences requiring MS discrimination. Retention times typically were very stable within batches (%CV ≤ 0.5%), although this appeared to be analyte and column dependent. Chromatographic peak shape was good (symmetrical) and stable over the period of the testing without any change of column. Our results suggest that SFC‐MS is a sensitive, reproducible and robust analytical tool ready to be used in anti‐doping laboratories alongside the currently applied techniques such as gas and liquid chromatography coupled to mass spectrometry. Even if instruments are designed slightly differently, all three setups demonstrated their fitness for the purpose in anti‐doping testing.

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Quality by design approach for enantioseparation of terbutaline and its sulfate conjugate metabolite for bioanalytical application using supercritical fluid chromatography

Cited by 8 publications

References 32 publications

Recent Advances in Separation and Analysis of Chiral Compounds

Recent Advances in Separation and Analysis of Chiral Compounds

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Routine application of SFC‐MS in doping control: Analysis of 3 × 1000 urine samples using three different SFC‐MS instruments

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