Method development and validation for the determination of Mirtazapine and Warfarin in the raw material using polar phase liquid phase high performance liquid chromatography.

摘要

It is generally recognized that the most useful stationary phase for resolution of a wide range of racemates consists of polysaccharides, such as phenylcarbamates including Amylose and Cellulose. The stationary phases are characterized by high recognition ability, larger applicability and stronger loading capacity.;A polar- organic liquid chromatography method was developed for the separation of Mirtazapine and Warfarin enantiomers. An HPLC method was developed using two columns with different Polysaccharide stationary phases. The stationary phase of the first column consisted of a mixtures of 50% of amylose tris(3,5dimethylphenylcarbamate)(Chiral pack AD-H)(ADMPC) and 50% of cellulose tris(3,5dimethylphenylcarbamate) (Chiral cell OD-H)(CDMPC). The stationary phase of the second column consisted of cellulose-1 tris (3, 5-dimethylphenylcarbamate) (Chiral cell OD-H) (CDMPC). The separation was achieved using both polar and normal organic phases.;The desired separation of Warfarin was not accomplished due to rapid decomposition of the compound. However, a satisfactory method for separation of Mirtazapine enantiomers was developed and validated. All the validation results obtained were satisfactory and acceptable under ICH guidelines, except for tailing factor that started to increase, which was related to high-pressure problem with the column at flow rate 0.6ml/min.