Development of micellar electrokinetic chromatography method for the determination of three defined impurities in indomethacin

Riasová, Petra; Doubková, Dagmar; Pincová, Lucie; Jung, Ondřej; Polášek, Miroslav; Jáč, Pavel

doi:10.1002/elps.201800080

Cited by 7 publications

(6 citation statements)

References 14 publications

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“…Then, according to the characteristics of different separation modes, some important basic operating conditions are optimized to explore their impacts on some indicators such as separation degree, resolution, repeatability, and separation time, and finally, obtain the best separation conditions [43]. Typical examples are listed in Table 2 [44][45][46][47][48][49][50][51][52][53][54][55][56][57] and systematically discussed under the diverse separation modes in the following sections.…”

Section: Capillary Electrophoresis (Ce)mentioning

confidence: 99%

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

et al. 2022

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Design of experiment (DoE) techniques have been widely used in the field of chromatographic parameters optimization as a valuable tool. A systematic literature review of the available DoE techniques applied to the development of a chromatographic analysis method is presented in this paper. First, the most common available designs and the implementation steps of DoE are comprehensively introduced. Then the studies in recent 10 years for the application of DoE techniques in various chromatographic techniques are discussed, such as capillary electrophoresis, liquid chromatography, gas chromatography, thin‐layer chromatography, and high‐speed countercurrent chromatography. Current problems and future outlooks are finally given to provide a certain inspiration of research in the application of DoE techniques to the different chromatographic techniques field. This review contributes to a better understanding of the DoE techniques for the efficient optimization of chromatographic analysis conditions, especially for the analysis of complex systems, such as multicomponent drugs and natural products.

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Section: Capillary Electrophoresis (Ce)mentioning

confidence: 99%

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

et al. 2022

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“…The central composite face‐centered design was also used for the optimization of a BGE composition in a study published by Riasová et al. [115]. In this case, 58 mM SDS prepared in 20 mM sodium phosphate buffer (pH 7.57) enabled the separation of nonsteroidal anti‐inflammatory agent indomethacin and its three related substances.…”

Section: Electrokinetic Chromatographymentioning

confidence: 99%

“…The fundamental role of SDS in modulating and obtaining the separation was thus explained by its influence on both the stability and the type of complexes between γ-CD and the analytes. The central composite face-centered design was also used for the optimization of a BGE composition in a study published by Riasová et al [115]. In this case, 58 mM SDS prepared in 20 mM sodium phosphate buffer (pH 7.57) enabled the separation of nonsteroidal anti-inflammatory agent indomethacin and its three related substances.…”

Section: Mekc- Meekc- Lekc-uvmentioning

confidence: 99%

“…Careful modulation of system selectivity then may provide a resolution of even very demanding analytes. A summary of MEKC-, MEEKC-, and liposome-EKC (LEKC)-UV methods applicable to quality control of pharmaceuticals published during the review time period is provided in Table 4 [39,[112][113][114][115][116][117][118][119][120][121][122][123].…”

Section: Mekc- Meekc- Lekc-uvmentioning

confidence: 99%

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Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review

Řemínek

Foret

2020

Electrophoresis

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Capillary electrophoresis represents a promising technique in the field of pharmaceutical analysis. The presented review provides a summary of capillary electrophoretic methods suitable for routine quality control analyses of small molecule drugs published since 2015. In total, more than 80 discussed methods are sorted into three main sections according to the applied electroseparation modes (capillary zone electrophoresis, electrokinetic chromatography, and micellar, microemulsion, and liposome-electrokinetic chromatography) and further subsections according to the applied detection techniques (UV, capacitively coupled contactless conductivity detection, and mass spectrometry). Key parameters of the procedures are summarized in four concise tables. The presented applications cover analyses of active pharmaceutical ingredients and their related substances such as degradation products or enantiomeric impurities. The contribution of reported results to the current knowledge of separation science and general aspects of the practical applications of capillary electrophoretic methods are also discussed.

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“…However, the test solution of BPAA was prepared in 50% (v/v) aqueous methanol (MeOH) at an unusually high concentration of 2.5 mg/mL [11]. Such high concentrations are typically used for the impurity profiling in pharmaceutical analysis [12,13]. Since BPAA may react with nucleophiles such as water [14] and MeOH yielding α‐hydroxyphenylacetic (mandelic) acid (MA) and α‐methoxyphenylacetic acid (MPAA) as shown in Figure 1, it might be possible that the stability of BPAA is compromised under applied experimental conditions [11].…”

Section: Introductionmentioning

confidence: 99%

Stability study of α‐bromophenylacetic acid: Does it represent an appropriate model analyte for chiral separations?

et al. 2020

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The stability of α-bromophenylacetic acid (BPAA) in 50% aqueous methanol solution has been tested. CE in different running buffers was used to separate BPAA from the decomposition reaction products α-hydroxyphenylacetic (mandelic) acid and αmethoxyphenylacetic acid. Suitable CE separation of all three compounds and other product, bromide, was achieved in 60 mmol/L formate buffer (pH 3.0) at −30 kV in 50 μm (i.d.) poly(vinyl alcohol)-coated fused silica capillary (30 cm/24.5 cm) with UV detection at 200 nm. The CE method was applied to determine the reaction order of the decomposition of BPAA (0.47 mmol/L) via nucleophilic substitution in 50% aqueous methanol. The first-order reaction kinetics was confirmed by linear and non-linear regression, giving the rate constants 1.52 × 10 −4 ± 2.76 × 10 −5 s −1 and 7.89 × 10 −5 ± 5.02 × 10 −6 s −1 , respectively. Additionally, the degradation products were identified by CE coupled to mass spectrometric (MS) detection. The CE-MS experiments carried out in 60 mmol/L formate buffer (pH 3.0) and in 60 mmol/L acetate buffer (pH 5.0) confirmed the results obtained by CE-UV. Furthermore, the stability of BPAA in polar solvents was tested by 1 H NMR experiments. Our results provide strong evidence of the instability and fast degradation of BPAA in 50% aqueous methanol indicating that BPAA is not suitable as the model analyte for chiral separations.

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Development of micellar electrokinetic chromatography method for the determination of three defined impurities in indomethacin

Cited by 7 publications

References 14 publications

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review

Stability study of α‐bromophenylacetic acid: Does it represent an appropriate model analyte for chiral separations?

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