Determinação dos enantiômeros da atropina em soluções oftálmicas empregando a cromatografia líquida de alta eficiência com fase estacionária quiral / Determination of atropine enantiomers in ophthalmic solutions by liquid chromatography using a chiral stationary phase

AUTOR(ES)
DATA DE PUBLICAÇÃO

2007

RESUMO

There are many therapeutic agents commercialized under racemic form. The enantiomers can show significant differences in the pharmacokinetic and pharmacodynamic profiles. The use of pure enantiomer in pharmaceutical formulations can result in better adjustment of dose and less adverse effects. Atropine, an alkaloid of the Atropa belladonna, is a racemic mixture of l-hyoscyamine and d-hyoscyamine. This drug is mainly used to dilate the pupil and as an antispasmodic agent. To quantify these enantiomers analytical methods were developed, using high performance liquid chromatography (HPLC) with chiral stationary phases Chiralcel OD® and Chiral AGP®. To quantify these enantiomers in ophthalmic solutions the validation of a HPLC method was performed using a Chiral AGP® column at 20°C. The mobile phase consisted of a buffered phosphate solution (containing 10 mM 1-octanesulfonic acid sodium salt and 7.5 mM triethylamine, adjusted to pH 7.0 with ortho-phosphoric acid) and acetonitrile (99:1 v/v). The flow rate was 0.6 mL/min, with ultraviolet detection at 205 nm. In the concentration range from 14.0 mg/mL to 26.0 mg/mL, the method is linear (r >0.9999), exact (100.1% - 100.5%) and precise (RSDsystem ≤ 0.6%; RSDintra-day ≤ 1.1%; RSDinter day ≤ 0.9%). The method is specific and the validation tests assure that standard and sample solutions are stable for up to 72 hours. The factorial design assures the robustness with variation of ± 10% in the mobile phase components and 2°C of column temperature.

ASSUNTO(S)

clae com fase quiral hiosciamina solução (formas farmacêuticas) (desenvolvimento alcalóides (pesquisa) atropina controle físico-químico de qualidade dos medicamentos chiral agp® alkaloids hyosciamine chiralcel od® ophtalmology chiral hplc chiral agp® chiralcel od® oftalmologia (estudo) cromatografia líquida de alta eficiência (aplicações) atropine

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