Reference

Ion-pair RP-LC of tegaserod maleate and its impurities in pharmaceutical formulations and in dissolution studies

All Rights Reserved. Ion-pair RP-LC of tegaserod maleate and its impurities in pharmaceutical formulations and in dissolution studies. Yang, B.; Gao, M. J.; Duan, G. L. (Department of Pharmaceutical Analysis, School of Pharmacy, Fudan University, Shanghai 200032, Peop. Rep. China). Chromatographia, 63(9-10), 431-436 (English) 2006 Vieweg Verlag/GWV Fachverlage GmbH. CODEN: CHRGB7. ISSN: 0009-5893. DOCUMENT TYPE: Journal CA Section: 64 (Pharmaceutical Analysis) A simple ion-pair reversed-phase high-performance liq. chromatog. (RP-HPLC) method was developed for detn. of tegaserod maleate and related impurities in tablet dosage forms. The mobile phase was (vol.Several substances with their cas registry numbers 189188-57-6 and 10601-19-1 may be metioned in this study./vol.) acetonitrile-25 mmol L-1 sodium dodecyl sulfate, adjusted to pH 2.6 with glacial acetic acid. A C18 column was used as stationary phase and UV detection was at 314 nm. The method was optimized and validated. Response was linearly dependent on concn. between 0.1 and 100 mg mL-1 with a limit of quantification (LOQ) of 0.1 mg mL-1 for tegaserod maleate (S/N = 10). Under optimum conditions, tegaserod maleate was successfully sepd. from related substances, including 5-methoxyindole-3-carboxaldehyde remaining after synthesis and other impurities possibly resulting from oxidization and decompn. The excipients did not interfere with assay of tegaserod maleate in tablet dosage forms. It is suggested that the proposed method can be used for routine quality control and dosage-form assay of tegaserod maleate. .