PubMed · 4380327
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1966. A long-acting antihistamine.. https://pubmed.ncbi.nlm.nih.gov/4380327/
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Charged cyclodextrin-mediated capillary electrophoretic methods (capillary zone electrophoresis [CZE] and isotachophoresis [ITP]) in a hydrodynamically closed separation system with suppressed electroosmotic flow and UV absorbance photometric detection (for CZE) or conductivity detection (for ITP) were developed for a highly effective separation and quantitation of dimethindene enantiomers in various pharmaceutical formulations (solution, gel, capsules). Optimized electrolyte systems were based on low-mobility buffer constituents (epsilon-aminocaproic acid, beta-alanine, potassium acetate, acetic acid), negatively charged (at pH > 4.5) carboxyethyl-beta-cyclodextrin (CE-beta-CD), serving as chiral selector, and methylhydroxyethylcellulose, serving as an electroosmotic flow suppressor. Complete enantioseparations of dimethindene in the presence of low concentrations of CE-beta-CD (2.5 mg/ml in CZE, 6.0 mg/ml in ITP) clearly indicated a role of charge of this chiral selector in enantioresolution. It also outlined the potential of charged CD-derivatives as chiral selectors for various CE techniques. The proposed methods were successfully validated, appraising parameters of sensitivity, linearity, precision, accuracy/recovery, and robustness, and then, they were applied to pharmaceutical samples. Consistent results obtained by both CE methods indicate their usefulness for routine use.
Capillary isotachophoresis was employed to separate and determine dimethinden enantiomers in various dosage forms. Several types of chiral selectors were tested in various electrolyte systems of different composition and different pH. The optimal leading electrolyte was composed of 10 mmol/l potassium acetate and acetic acid to achieve pH 4.8 with an addition of 4 mmol/l carboxyethyl-beta-cyclodextrin as the chiral selector and 0.2% of methylhydroxyethylcellulose (m-HEC) to suppress the electroosmotic flow. The terminating electrolyte was betaalanine of a concentration of 5 mmol/l. The evaluation included the precision, correctness, linearity, robustness, and selectivity of the elaborated ITP method. The pretreatment of the sample prior to analysis consisted in the dissolution and dilution of the appropriate dimethinden-containing dosage form with demineralized water to achieve the required concentration. Such a pretreated sample was directly dosed into the apparatus.
Capillary isotachophoresis was employed to determine dimethindene in various dosage forms. Several electrolyte systems of varying compositions and varying pH were tested. For validation of the method and the determination of dimethindene in real samples (gel, drops, capsules), two electrolyte systems were selected. Precision, correctness, linearity, robustness, and selectivity of the ITP method were evaluated for both electrolyte systems. The pre-treatment of the sample prior to analysis consisted in dissolving and diluting the pertinent dosage form containing dimethindene with demineralized water to the required concentration. The sample adjusted in this way was directly dosed into the apparatus.