Content Determination of Aprindine Hydrochloride Tablets and Its Related Substances by RP-HPLC

OBJECTIVE:To develop the method for the content determination of Aprindine hydrochloride tablets and its related substances. METHODS:RP-HPLC method was adopted. The determination was performed on Dikma Diamonsil C18 column with mobile phase consisted of methanol-water-10% tetrabutyl ammonium hydroxide(40∶60∶2.0,V/V/V,adjusted to 3.0 using phosphoric acid)at the flow rate of 1.0 ml/min. The detection wavelength was set at 258 nm,and column temperature was 30 ℃. Sample size was 10 μl. RESULTS:The linear range of aprindine hydrochloride were 25.55-204.40 μ g/ml(r=0.999 4);RSDs of precision,stability and reproducibility tests were lower than 0.6%;the average recovery was 100.1%(RSD=0.5%,n=9);the total amount of impurities was lower than 0.84%. CONCLUSIONS:The method is simple,accurate,specific and sensitive,and can be used for quality control of Aprindine hydrochloride tablets.