A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma.

摘要

A new, precise, simple and accurate HPLC method was developed for the first time to separate and determine mebeverine enantiomers. Enantiomeric resolution was achieved on a cellulose Tris (3,5-dimethylphenyl carbamate) column known as Chiralcel OD, with UV detection at 263 nm. The mobile phase consisted of n-hexane, isopropyl alcohol and triethylamine (90:9.9:0.1 v/v/v). Sample run time was 18 min. On using the chromatographic conditions described, mebeverine enantiomers were well resolved with mean retention times of about 11 and 14 min. A linear response (r>0.999) was observed over the concentration range 0.5-20 microg/mL racemic mebeverine. Precision, accuracy and stability were studied according to ICH guidelines. The limit of detection was found to be 0.05 microg/mL for each enantiomer of mebeverine. The proposed method was applied for analysis of mebeverine in commercially available tablets dosage formulations. Examples of application to biological samples are also given. Reanalysis of samples several weeks after the initial analysis showed no degradation of mebeverine.