Separation of Dimetinden Enantiomers in Drugs by Means of Capillary Isotachophoresis

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Separácia enantiomérov dimetindenu v liekoch kapilárnou izotachoforézou

Kapilárna izotachoforéza bola využitá na separáciu a stanovenie enantiomérov dimetindenu v rôznych liekových formách. Bolo preskúšaných niekoľko typov chirálnych selektorov vo viacerých elektrolytových systémoch s rôznym zložením a rôznym pH. Optimálny vodiaci elektrolyt bol tvorený 10 mmol/l octanom draselným a kyselinou octovou do výslednej hodnoty pH 4,8 s prídavkom 4 mmol/l karboxyetyl-β-cyklodextrínu ako chirálneho selektora a 0,2% metylhydroxyetylcelulózy (m–HEC) na potlačenie elektroosmotického toku. Ako zakončujúci elektrolyt sa použil β-alanín s koncentráciou 5 mmol/l. Bola hodnotená presnosť, správnosť, linearita, robustnosť a selektivita vypracovanej ITP metódy. Predúprava vzorky pred analýzou spočívala v rozpustení a nariedení príslušnej liekovej formy s obsahom dimetindenu demineralizovanou vodou na požadovanú koncentráciu. Takto upravená vzorka bola priamo dávkovaná do prístroja.

Klúčové slová:
izotachoforéza – chirálna separácia – dimetinden – liek – elektroforéza

Authors: P. Kubačák; P. Mikuš‚; I. Valášková; Emil Havránek
Authors‘ workplace: Univerzita Komenského v Bratislave, Farmaceutická fakulta, Katedra farmaceutickej analýzy a nukleárnej farmácie, SR
Published in: Čes. slov. Farm., 2006; 55, 32-35
Category: Original Articles

Overview

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-β-cyclodextrin as the chiral selector and 0.2 % of methylhydroxyethylcellulose (m–HEC) to suppress the electroosmotic flow. The terminating electrolyte was β- alanine 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.

Key words:
isotachophoresis – chiral separation – dimethinden – drug – electrophoresis

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Article was published in

Czech and Slovak Pharmacy

2006 Issue 1