Simultaneous determination of chiral and achiral impurities of ivabradine on a cellulose tris(3-chloro-4-methylphenylcarbamate) chiral column using polar organic mode

Ferencz, Elek; Kovács, Béla; Boda, Francisc; Foroughbakhshfasaei, Mohammadhassan; Kelemen, Éva Katalin; Tóth, Gergő; Szabó, Zoltán‐István

doi:10.1016/j.jpba.2019.112851

Cited by 28 publications

(18 citation statements)

References 18 publications

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“…In the latter case, low model validity was observed, which was due to the high reproducibility of replicate runs and thus, low pure error inside the models. Similar observations were described during several chromatographic method optimizations [26][27][28].…”

Section: Ce Methods Developmentsupporting

confidence: 84%

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

et al. 2021

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is a recently approved drug used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea. Herein, a capillary electrophoretic method was developed, enabling the simultaneous analysis of the API and its S-enantiomer in addition to the enantiomers of its major impurity phenylalaninol. Twenty-nine different cyclodextrins (CDs), including native, neutral, and charged ones were screened as potential chiral selectors, and the best results were obtained with sulfated CDs. Randomly sulfated-β-CD exhibited outstanding enantioresolution, the peaks of phenylalaninol enantiomers inserted between the two peaks of solriamfetol enantiomers, while sulfated-γ-CD (S-γ-CD) showed remarkable resolution values in a much shorter analysis time with the optimal enantiomer migration order. Among the single isomer sulfated CD derivatives, substituent dependent enantiomer migration order reversal could also be observed in the case of heptakis(6-O-sulfo)-β-CD (HS-β-CD) or heptakis(2,3-O-dimethyl-6-O-sulfo)β-CD (HDMS-β-CD) with R-,S-solriamfetol, and heptakis(2,3-O-diacetyl-6-O-sulfo)-β-CD (HDAS-β-CD) resulting S-,R-solriamfetol migration order. The sulfated-γ-CD system was chosen for method optimization applying orthogonal experimental design. The optimized method (45 mM Tris-acetate buffer, pH 4.5, 4 mM S-γ-CD, 21°C, +19.5 kV) was capable for the baseline separation of solriamfetol and phenylalaninol enantiomers within 7 min. The optimized method was validated according to the ICH guidelines and successfully applied for the analysis of pharmaceutical preparation (Sunosi ® 75 mg tablet), thus it may serve as a routine procedure for the laboratories of regulatory authorities as well as in Pharmacopoeias.

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Section: Ce Methods Developmentsupporting

confidence: 84%

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

et al. 2021

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“…Seven different Lux amylose- and cellulose-based columns were tested to resolve ivabradine enantiomers and only Lux Cellulose-2 was successful. The method was validated and used to analyze R -enantiomer content below 0.05% in tablet [ 54 , 55 ]. A similar study was performed for a new potential drug to treat patients suffering with narcolepsy.…”

Section: Polysaccharide-based Stationary Phasesmentioning

confidence: 99%

An overview of chiral separations of pharmaceutically active substances by HPLC (2018–2020)

Grybinik

Bosáková

2021

Monatsh Chem

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Graphic abstract This review provides a brief survey of chiral separation of pharmaceutically active substances published over the last 3 years (2018–2020). Chiral separation of drugs is an important area of research. The control of enantiomeric purity and determination of individual enantiomeric drug molecules is a necessity especially for clinical, analytical, and regulatory purposes. Among chromatographic resolution methods, high-performance liquid chromatography based on chiral stationary phases remains the most popular and effective method used for chiral separation of various drugs. In this review, attention is paid to several classes of chiral stationary phases that have been the most frequently used for drug enantioseparation during this period.

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“…Numerous reverse phase HPLC methods optimized using AQbD are published, but there are several using gradient HILIC (hydrophilic interaction chromato graphy) methods as well (53). Using isocratic HPLC methods, the most frequent CMPs are the aforementioned input variables (54,55).…”

Section: Quality-by-design In the Development Of Analytical Methods And Pharmaceutical Manufacturingmentioning

confidence: 99%

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

et al. 2021

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Current pharmaceutical research directions tend to follow a systematic approach in the field of applied research and development. The concept of quality-by-design (QbD) has been the focus of the current progress of pharmaceutical sciences. It is based on, but not limited, to risk assessment, design of experiments and other computational methods and process analytical technology. These tools offer a well-organized methodology, both to identify and analyse the hazards that should be handled as critical, and are therefore applicable in the control strategy. Once implemented, the QbD approach will augment the comprehension of experts concerning the developed analytical technique or manufacturing process. The main activities are oriented towards the identification of the quality target product profiles, along with the critical quality attributes, the risk management of these and their analysis through in silico aided methods. This review aims to offer an overview of the current standpoints and general applications of QbD methods in pharmaceutical development.

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Simultaneous determination of chiral and achiral impurities of ivabradine on a cellulose tris(3-chloro-4-methylphenylcarbamate) chiral column using polar organic mode

Cited by 28 publications

References 18 publications

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

An overview of chiral separations of pharmaceutically active substances by HPLC (2018–2020)

Quality-by-design in pharmaceutical development: From current perspectives to practical applications

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