Enantioselective analysis of fluoxetine in pharmaceutical formulations by capillary zone electrophoresis

Cârcu-Dobrin, Melania; Budău, Monica; Hancu, Gabriel; Gagyi, László; Rusu, Aura; Kelemen, Hajnal

doi:10.1016/j.jsps.2016.09.007

Cited by 29 publications

(18 citation statements)

References 20 publications

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“…The up-to-date "quality by design" approach has been successfully used in the pharmaceutical development and characterisation of tablets, optimization of tablet formulations (12,13) and also for the analytical method development and validation of HPLC (14,15) and other analytical methods (16). Design of experiments (DoE) has many advantages in pharmaceutical drug formulations and analytical method development and validation in comparison with techniques like changing one factor at a time (COST).…”

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confidence: 99%

Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

et al. 2018

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A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental design was used to demonstrate the robustness of the method. Strontium ranelate was eluted at 4.4 minutes and showed no interference with the excipients used in the formulation, at 321 nm. The method is linear in the range of 20-320 μg mL-1 (R2 = 0.99998). Recovery, tested in the range of 40-120 μg mL-1, was found to be 96.1-102.1 %. Intra-day and intermediate precision RSDs ranged from 1.0-1.4 and 1.2-1.4 %, resp. The limit of detection and limit of quantitation were 0.06 and 0.20 μg mL-1, resp. The proposed technique is fast, cost-effective, reliable and reproducible, and is proposed for the routine analysis of strontium ranelate.

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Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

et al. 2018

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“…Another chiral separation method for FLX using a phosphate buffer at pH 5.0 and a neutral CD derivative [heptakis(2,3,6‐tri‐ O ‐methyl)‐ β ‐CD – TRIMEB] was developed by Cârcu‐Dobrin et al (); in order to optimize separation a factorial analysis study was performed by orthogonal experimental design in which several factors were varied at the same time; a good separation with short migration time (<5 min) and good chiral resolution was obtained. The method was applied for determination of FLX enantiomers from pharmaceutical preparations.…”

Section: Methodsmentioning

confidence: 99%

Analytical methodologies for the stereoselective determination of fluoxetine: An overview

Hancu

Cârcu-Dobrin

Budău³

et al. 2017

Biomedical Chromatography

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Fluoxetine is a widely used antidepressant belonging to the selective serotonin reuptake inhibitor class; it is used in the treatment of major depression, obsessive compulsive, premenstrual dysphoric, panic and post-traumatic stress disorders. Fluoxetine is an optical active pharmaceutical substance, which is used as a racemate in therapy, but stereospecific interactions associated with the serotonin-reuptake carrier, for both the parent drug and its active metabolite, norfluoxetine, have been described in the literature. Therefore, the stereoselective analysis of fluoxetine and norfluoxetine is important in order to characterize the pharmacokinetic and pharmacodynamic profile of the analytes. Several chromatographic and electrophoretic methods have been published in the literature for the chiral discrimination of fluoxetine enantiomers from different matrices. The purpose of the current review is to provide a systematic survey of the analytical techniques used for the chiral determination of fluoxetine and norfluoxetine covering a period of~25 years.

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“…An overview of EKC‐UV methods applicable for quality control of pharmaceuticals published since 2015 is provided in Table 3 [71–106]. The most frequently, CDs were used as chiral selectors in these works, owning to their advantages, such as low cost, good stability, low UV cut‐off, high water solubility, and excellent chiral selectivity.…”

Section: Electrokinetic Chromatographymentioning

confidence: 99%

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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Enantioselective analysis of fluoxetine in pharmaceutical formulations by capillary zone electrophoresis

Cited by 29 publications

References 20 publications

Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

Analytical methodologies for the stereoselective determination of fluoxetine: An overview

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

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