A new RP-HPLC method for analysis of mebeverine hydrochloride in raw materials and tablets.

A simple, sensitive, selective, reliable, least time consuming and rapid high-performance liquid chromatographic method for the determination and quantification of mebeverine hydrochloride using hyoscine butylbromide as internal standard has been developed. The chromatographic system consisted of a Shimadzu LC-10 AT VP pump, SPD-10 AV VP UV visible detector, and a CBM-102 Bus Module integrator. Separation was achieved on the micro Bondapak 125 a C18 10microm column at room temperature. The samples were introduced through an injector valve with a 10 microl sample loop. Acetonitrile-water (1:1 v/v) was used as mobile phase, with flow rate 1.7 ml/minutes. pH was adjusted to 2.9 with phosphoric acid. U.V detection was performed at 205 nm. The results obtained showed a good agreement with the declared content. Recovery values of mebeverine hydrochloride were from 99.80% to 100.13%. The proposed method is rapid, accurate, and selective and may be used for the quantitative analysis of mebeverine hydrochloride. The method was found to be specific, accurate, precise and reliable for the determination and quantification of mebeverine hydrochloride in form of raw materials, in bulk drugs and formulation. It was possible to determine all of them in the concentration range of 5-30 nano grams. The detection limit of mebeverine hydrochloride was 0.4-nano gram.