Quantitative capillary gel electrophoresis assay of phosphorothioate oligonucleotides in pharmaceutical formulations.

Srivatsa, G S; Batt, M; Schuette, J; Carlson, R H; Fitchett, J; Lee, C; Cole, D L

Srivatsa, G S; Batt, M; Schuette, J; Carlson, R H; Fitchett, J; Lee, C; Cole, D L.

Afiliación

Srivatsa GS; Development Chemistry Department, Isis Pharmaceuticals, Inc., Carlsbad, CA 92008.

J Chromatogr A ; 680(2): 469-77, 1994 Oct 07.

Article en En | MEDLINE | ID: mdl-7981828

RESUMEN

Quantitative capillary gel electrophoresis (QCGE) has been developed for the accurate quantitation of a 21-mer phosphorothioate oligonucleotide, ISIS 2922, and its degradation products in an intravitreal formulation. The electrokinetic mode of injection employed by CGE necessitates formulation of the external reference standard in a sample matrix similar to that of the drug product and the use of an internal standard for improved accuracy and precision. The analytical method detailed in this paper has demonstrated the necessary accuracy, precision, linearity, range, selectivity and ruggedness for use in routine drug product analysis and stability monitoring of phosphorothioate oligonucleotides.

Asunto(s)

Electroforesis en Gel de Poliacrilamida/métodos; Preparaciones Farmacéuticas/análisis; Tionucleótidos/análisis; Acción Capilar; Electroforesis en Gel de Poliacrilamida/estadística & datos numéricos; Cinética; Control de Calidad; Reproducibilidad de los Resultados; Sensibilidad y Especificidad; Tecnología Farmacéutica

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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tionucleótidos / Preparaciones Farmacéuticas / Electroforesis en Gel de Poliacrilamida Tipo de estudio: Diagnostic_studies Idioma: En Revista: J Chromatogr A Año: 1994 Tipo del documento: Article Pais de publicación: Países Bajos

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