Abstract
A simple ion-pair reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for determination of tegaserod maleate and related impurities in tablet dosage forms. The mobile phase was 60:40 (v/v) 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 concentration between 0.1 and 100 µg mL−1 with a limit of quantification (LOQ) of 0.1 µg mL−1 for tegaserod maleate (S/N = 10). Under optimum conditions, tegaserod maleate was successfully separated from related substances, including 5-methoxyindole-3-carboxaldehyde remaining after synthesis and other impurities possibly resulting from oxidization and decomposition. 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.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
