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Holland, Lisa; Chetwyn, Nik P.; Perkins, Melissa D.; Lunte, Susan M.

doi:10.1023/a:1012018709641

Cited by 63 publications

(27 citation statements)

References 82 publications

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“…11) CE separations are generally more efficient, can be performed faster and require only nanoliter injection volumes. 12) Capillary zone electrophoresis (CZE) and micellar electrokinetic chromatography (MEKC) are the two most widely used separation modes of this technique. 13,14) In MEKC, ionic or neutral surfactants are added to the operating buffer at a concentration above their critical micelle concentration.…”

Section: )mentioning

confidence: 99%

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

Sfair

Gobetti

Sangoi

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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A simple, stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for the analysis of mianserin hydrochloride in coated tablets. The method employed (hydroxymethyl)aminomethane (TRIS) 50 mM to which sodium dodecyl sulfate (SDS) 50 mM was added at pH 10.6 as the electrolyte and the voltage applied was 25 kV. The capillary used was 48.5 cm long (40.0 cm effective length and 50.0 µm i.d.) and the detection wavelength was 220 nm. Tetracycline was used as internal standard. The method was validated in accordance with the International Conference on Harmonization (ICH) requirements, which involved specificity, linearity, precision, accuracy and robustness. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using photodiode array detection. The degradation products formed under photolytic and oxidative conditions were investigated by electrospray ionization mass spectrometry. The method was linear over the concentration range of 50-130 µg/mL. The method was precise as demonstrated by an inter-day and intra-day relative standard deviation of less than 2.0%. The proposed validated MEKC method showed recoveries between 98.16 and 102.80% of the nominal contents. The Plackett-Burman design was applied for the robustness test in order to examine potential sources of variability by screening a large number of factors in a relatively small number of experiments.Key words capillary electrophoresis; mianserin hydrochloride; mass spectrometry Mianserin hydrochloride (Fig. 1) is a drug for the treatment of depressive illness and depression associated with anxiety. Its antidepressant effect is mainly attributed to presynaptic alfa2-adrenoreceptor blocking activity and to serotonin receptor antagonism. Mianserin is classified as an atypical antidepressant, based on its undefined action mechanism. 1)This drug is considered a weak base with two pK a values (2.7, 8.26) and chemically known as (RS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c, f ] pyrazino[1,2-α] azepine hydrochloride. In humans, its major metabolic pathways include 8-hydroxylation, N-demethylation, and N-oxidation catalyzed mainly by CYP2D6, and by CYP3A4 and 1A2.2) In rats, the additional metabolite, 8-hydroxy-N-desmethylmianserin is formed from 8-hydroxyminaserin and/or N-desmethylmianserin. 3)From the analytical point of view, methods for its determination in biological fluids [4][5][6] and dosage form 7) have been reported. However, none of the reported methods for the determination of mianserin hydrochloride was shown to be a stability-indicating. It was therefore important to develop and validate a capillary electrophoresis stability-indicating method for this major compound, that can be employed in stability studies and routine quality control of its preparations. In the literature were found three relevant publications on the determination of mianserin enantiomers by capillary electrophoresis (CE). [8][9][10] The use of CE in the pharm...

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Section: )mentioning

confidence: 99%

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

Sfair

Gobetti

Sangoi

et al. 2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…There is a multitude of detection techniques available for electrophoresis and chromatography and a detailed comparison is beyond the scope of this manuscript (for reviews see [5,65,66]). The most common detection modes include optical absorption, fluorescence, and radioactivity, where analyte identification is based on retention/migration times (or migration distances) that are determined using standards.…”

Section: Information-rich Detection In Chromatography and Electrophormentioning

confidence: 99%

“…On-line EC detection is limited to compounds that are selectively oxidized or reduced at the electrode surface [65]. Consequently, EC (potentiometric and/or amperometric) detection is suitable for analysis of select components in complex biological fluids [79,80].…”

Section: Information-rich Detection In Chromatography and Electrophormentioning

confidence: 99%

Fluorescence line-narrowing detection in chromatography and electrophoresis

Jankowiak¹,

Roberts²,

Small³

2000

Electrophoresis

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“…CE is a versatile technique and is rapidly developing as an alternative analytical tool with different separation mechanisms to LC [5]. In some fields, CE is currently displacing LC owing to its many advantageous features, such as extremely high efficiency, high resolution, rapid analysis, and small consumption of sample and reagents [6]. The small sample size and low consumption of reagents and organic solvents lead to a decrease in the cost analysis and further minor environmental damage.…”

Section: Introductionmentioning

confidence: 99%

Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method

Sangoi

Wrasse-Sangoi

Hurtado

et al. 2013

Acta Chromatographica

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Summary.A sensitive, fast, and stability-indicating micellar electrokinetic chromatographic (MEKC) method was developed and validated for the analysis of aliskiren (ALI) in tablets using nimesulide as internal standard (IS). Optimal conditions for the separation of ALI and its degradation products were investigated. The method employed 60 mM Tris buffer and 50 mM anionic detergent sodium dodecyl sulfate (SDS) solution at pH 9.8. MEKC method was performed on a fused-silica capillary (50 μm id; effective length, 40 cm). The capillary temperature was maintained at 35°C, and the applied voltage was 30 kV, with detection by photodiode array (PDA) detector set at 204 nm. The method was validated in accordance with the International Conference on Harmonisation (ICH) requirements. The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using PDA detection. The method was linear over the concentration range of 5-150 μg mL −1 (r 2 = 0.9996) of ALI. Intraday and interday precision and accuracy evaluated by relative standard deviation, respectively, were lower than 2%. The limit of detection was 1.31 µg mL −1 . The method proved to be robust by a one-variable-at-a-time evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI in tablets to support the quality control.

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Untitled

Cited by 63 publications

References 82 publications

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

Micellar Electrokinetic Chromatographic Method for Mianserin Hydrochloride and Analysis of Degradation Products by Mass Spectrometry

Fluorescence line-narrowing detection in chromatography and electrophoresis

Stress degradation studies on aliskiren and the development of a sensitive stability-indicating MEKC method

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