Application of High Pressure Liquid Chromatography to the Determination of Diastereoisomer in Methylphenidate Hydrochloride

G. R. Padmanabhan Ciba-Geigy Corporation, Pharmaceuticals., Division Research & Development Department, Suffern, New York, 10901

J. Fogel Ciba-Geigy Corporation, Pharmaceuticals., Division Research & Development Department, Suffern, New York, 10901

J. A. Mollica Ciba-Geigy Corporation, Pharmaceuticals., Division Research & Development Department, Suffern, New York, 10901

J. M. O'connor Ciba-Geigy Corporation, Pharmaceuticals., Division Research & Development Department, Suffern, New York, 10901

R. Strusz Ciba-Geigy Corporation, Pharmaceuticals., Division Research & Development Department, Suffern, New York, 10901; Gow-Mac Instrument Company, P.O. Box 22, Bound Brook, New Jersey, 08805

Abstract

A procedure for the quantitative analysis of the diastereoisomer in methylphenidate hydrochloride is described. The method is based on a high pressure liquid chromatographic separation of the isomers on a Sil-X column with a mobile phase containing ethanol, cyclohexane, chloroform and ammonium hydroxide. The method is simple, precise and accurate and has a limit of detection of 0.1% of the diastereoisomer in the drug substance.

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Application of High Pressure Liquid Chromatography to the Determination of Diastereoisomer in Methylphenidate Hydrochloride

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Application of High Pressure Liquid Chromatography to the Determination of Diastereoisomer in Methylphenidate Hydrochloride

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