The Study Of Ranitidine Hydrochloride And Related Substance In Its Injection

In this paper,a high Performance Liquid Chromatography methed used to determine the content and related substances of Ranitidine Hydrochloride, Ranitidine Hydrochloride injection was developed, and the methodological study of each was carried out as well. A High Performance Liquid Chromatography tandem Mass Spectrometry method was used for the analisis of the related substances in Ranitidine Hydrochloride and its injection. After separation and purification, confirming chemical structure of the purification, a High Performance Liquid Chromatography method was developed to realize qualitatively and quantitative analysis in the same time.This study includes the following four parts:First. RP-HPLC for the determination of the content and related substances in Ranitidine HydrochlorideThe current Chinese Pharmacopoeia method using gradient elution HPLC content of ranitidine hydrochloride and related substances in raw materials. In this paper, Diamonsial (?) C18 (150mm×4.6mm,5μm) column was used, methanol-5m mol. L-1 ammonium acetate (0.06%sodium heptane, triethylamine adjusted to pH 7.0) (68:32)as mobile phase,column temperature was 30℃, the flow rate was 1.0 mL. min-1, detection wavelength was 230 nm. The peak area (A) with the standard series of concentrations (C) linear regression, the regression equation:A= 64919.7C-44492.7, r= 0.9999, results show that 20-400μg. mL-1 range a good linear relationship. Pharmacopoeia of the method is more simple and quick.Second. RP-HPLC for the determination of the content and related substances in Ranitidine Hydrochloride InjectionIn this paper, Diamonsial (?) C18 (150 mm×4.6 mm,5μm) Column was used, methanol-5m mol. L-1 ammonium acetate (0.06% sodium heptane, triethylamine adjusted to pH 7.0) (68:32) as mobile phase,column temperature was 30℃, the flow rate was 1.0 mL. min-1, detection wavelength was 230 nm. The peak area (A) with the standard series of concentrations (C) linear regression, the regression equation:A=64919.7C-44492.7, r=0.9999, results show that 20-400μg. mL-1 range a good linear relationship.Third. Research of related substances in Ranitidine Hydrochloride.Using HPLC-MS of ranitidine hydrochloride and acid damage in high temperature conditions, the major related substances produced was analyzed, respectively, thin layer chromatography and liquid-liquid extraction of ranitidine hydrochloride acid after the material damage and heat damage in the separation of impurities in the coexistence of preparation, comprehensive utilization of MS and NMR confirmed the impurities in the acid degradation products of 5 - dimethylamino-2--FA, thermal degradation products N-2 [[[5-[(dimethylamino) methyl] 2-furyl] methyl] thio]-2--nitro acetamide.Forth. Study on the identification of N-2 [[[5-[(dimethylamino) methyl] 2-furyl] methyl] thio]-2--nitro in Ranitidine Hydrochloride injection.High performance liquid chromatography method was used to study on the identification of N-2 [[[5-[(dimethylamino) methyl] 2- furyl] methyl] thio]-2-nitro-acetamide in ranitidine hydrochloride injection.The use of additional self-correction factors was carried out in quantitative research methods.This study supplies a scientific basis for the quality control of the injection.