Content determination of ranitidine hydrochloride in compound ranitidine capsules by HPLC

Objective To establish an HPLC method to determine the content of ranitidine hydrochloride in compound ranitidine capsules.Methods The column was Kromasil C18(5 μm,4.6 mm×250 mm).The mixture of 0.6% Phosphoric acid solution(adjusting pH 7.10±0.05 with 50% sodium hydroxide solution)-acetonitrile(83 :17) was used as the mobile phase.The column temperature was 35 ℃,the flow rate was 1.0 mL min-1,the sample volume was 10 μL,and the detection wavelength was 230 nm.Results The linear range of ranitidine was 0.010 85-0.542 41 mg mL-1(r2= 0.999 7).The limit of quantification was 1.182 63 ng.The average recovery was 99.8%(n = 6),RSD = 1.0%.Conclusion The method is simple,sensitive,selective and accurate,which can be used for the content determination of ranitidine hydrochloride in compound ranitidine capsules.