Determination of Content and Related Substances in Aprindine Hydrochloride Tablets by HPLC / 中国药师

ABSTRACT

Objective:To establish a method for the determination of content and related substances in aprindine hydrochloride tablets by HPLC. Methods:A Waters symmetry-C18 column (150 mm × 4. 6 mm,5 μm) was used. The mobile phase was methanol -0. 02 mol·L-1 potassium dihydrogen phosphate (adjusting pH to 3. 0 with phosphoric acid) (50 50,v/v). The flow rate was 1. 0 ml·min-1 with the detection wavelength of 254 nm. The column temperature was 35℃, and the injection volume was 20μl. Results:The linear range of thioridazine was 3.0-22.5μg·ml-1(r=0.999 8). The average recovery was 99.8%(RSD=0.83%, n=9). The limit of detection and quantification was 40 ng and 300 ng, respectively. Conclusion:The method is simple, accurate, sensitive and reproducible, which can be used for the quality control of aprindine hydrochloride tablets.