Enantiomeric determination, validation and robustness studies of racemic citalopram in pharmaceutical formulations by capillary electrophoresis

Second-generation antidepressant drugs are increasingly prescribed world-wide by psychiatrists and primary care physicians. Generally speaking, they seem to be safer than traditional tricyclic antidepressant drugs, especially in overdose. However, most of them possess stereogenic centers, thus they can exist as enantiomeric couples. Since enantiomers can have even dramatically different pharmacokinetic and pharmacodynamic properties, the study of antidepressant chirality is of great importance. In fact, the application of enantioselective analytical techniques can be useful both for the quality control of enantiomerically pure formulations and for the pharmacovigilance and therapeutic monitoring of patients undergoing treatment with these drugs. The high efficiency and inexpensiveness of electrodriven methods makes them a very attractive alternative to the usual chromatographic methods. This review is an update (2004-2007) of a previously published paper on recent electrodriven methods for the enantioseparation of second-generation antidepressants. In particular, the focus has been put on selective serotonin reuptake inhibitors such as citalopram and sertraline, noradrenergic and specific serotonergic antidepressants, such as mirtazapine and tetracyclic antidepressants such as mianserin, as well as on multianalyte methods.

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“…Another two papers have been published on this topic in English-language journals [38,39]. Again, both papers are from a single research group.…”

Section: Citaloprammentioning

confidence: 97%

“…The first paper [38] presents a method for chirally resolving citalopram in less than 4 min for the quality control of formulations. The chiral selector is carboxymethyl-g-CD, used at a low concentration (0.15%) and at a low temperature (157C).…”

Section: Citaloprammentioning

confidence: 99%

Electrodriven methods for the enantioseparation of second‐generation antidepressant drugs: An update

Mandrioli

Raggi

2007

Electrophoresis

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“…A rapid method to assay citalopram racemate or escitalopram (S-citalopram) in tablets was reported [80]. The validation included an experimentally designed robustness test using the Plackett-Burman model.…”

Section: Pharmaceutical Applications Of Chiral Ce: Applicationsmentioning

confidence: 99%

Capillary electrophoresis for the analysis of small‐molecule pharmaceuticals

2006

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This paper reviews the application of CE to the analysis of small-molecule pharmaceuticals. The areas of pharmaceutical analysis covered are enantiomer separation, the analysis of small molecules such as amino acids or drug counter-ions, pharmaceutical assay, determination of related substances and physicochemical measurements such as log P and pK(a) of compounds. The different electrophoretic modes available and their advantages for pharmaceutical analysis are described. Recent applications of CE for each subject area are tabulated with electrolyte details.

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“…Two of them were the brand formulations from LILLY (Prozac ® ) and SOLVAY Pharma (Floxyfral ® ), the others were generic drugs from different countries. The declared amounts of the active ingredient in the various Table 1 Commercial formulations of fluoxetin (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15) and fluvoxamine (16)(17)(18)(19) All samples, as received, were stored in the dark at ambient temperature and humidity. They were all analysed within expiry dates.…”

Section: Solid Formulationsmentioning

confidence: 99%

Quality assessment of fluoxetine and fluvoxamine pharmaceutical formulations purchased in different countries or via the Internet by 19F and 2D DOSY 1H NMR

Trefi

Gilard

Balayssac

et al. 2008

Journal of Pharmaceutical and Biomedical Analysis

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Enantiomeric determination, validation and robustness studies of racemic citalopram in pharmaceutical formulations by capillary electrophoresis

Cited by 62 publications

References 20 publications

Electrodriven methods for the enantioseparation of second‐generation antidepressant drugs: An update

Electrodriven methods for the enantioseparation of second‐generation antidepressant drugs: An update

Capillary electrophoresis for the analysis of small‐molecule pharmaceuticals

Quality assessment of fluoxetine and fluvoxamine pharmaceutical formulations purchased in different countries or via the Internet by 19F and 2D DOSY 1H NMR

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