The new HPLC methodology for the chiral separation of tamsulosin enantiomers on amylose tris(3,5-dimethylphenylcarbamate) stationary phase

New chromatographic method for the enantioseparation of (R,S)-tamsulosin and the determination of (R)- and (S)-tamsulosin was developed with the aid of amylose tris(3,5-dimethylphenylcarbamate) stationary phase. The method was compared to the known procedure for tamsulosin enantioseparation on cellulose tris(3,5-dimethylphenyl carbamate). Careful validation of both methods allowed to prove advantages of the new procedure: significantly better resolution as well as twice better sensitivity. The method was applied to quantification of (R)- and (S)-tamsulosin contents in prolonged release Apo-Tamis 0.4 mg hard capsules (Apotex Europe B.V) and Omnic Ocas 0.4 mg coated tablets (Astellas).

► Sensitivity of the developed method is twice better than of previously reported one.
► Resolution of enantiomer's peaks is 7.93; Rs for cellulose-based phase—1.10.
► Precision of analyte determination is better when amylose phase is used.
► The method was validated according to ICH validation and analytical procedures.