Quantitative Determination of Main Component and the Related Substances in Betahistine Hydrochloride for Injection by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To determine the contents of betahistine hydrochloride and the related substances by HPLC.METHODS:The chromatographic separation was performed on Eclipse XDB-C18 column with column temperature at 25 ℃.The mobile phase consisted of water(sodium heptanesulfonate+10 mL triethylamine+810 mL water,with the pH adjusted to 3.0 with phosphoric acid) and methanol(8218) at a flow rate of 0.8 mL?min-1.The detection wavelength was 261 nm and the sample size was 50 ?L.RESULTS:The linear range of betahistine hydrochloride was 10～80 ?g?mL-1(r=0.999 3).The lowest detection limit was 2.84 ?g?mL-1 and the lowest quantitative limit was 3.01 ?g?mL-1.The average recovery was 99.8%(RSD=0.3%).The average content for the related substances in 3 batches of samples was 0.13%.CONCLUSION:The method is simple,rapid,accurate and reliable,and suitable for the quality control of betahistine hydrochloride.