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The Study of Ranitidine Hydrochloride and Related Substance in Its Injection

Author: WangLiJie
Tutor: ShiJie；WenJingWei
School: Zhengzhou University
Course: Analytical Chemistry
Keywords: Ranitidine hydrochloride HPLC Content Related substances High performance liquid chromatography-tandem mass structure
CLC: R927.2
Type: Master's thesis
Year: 2011
Downloads: 110
Quote: 0
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Abstract


This establishment ranitidine hydrochloride raw materials, injection and related substances measured by HPLC were carried out methodological studies; ranitidine hydrochloride injection and its related substances studied, separation purification impurities, structural confirmation; And for the first time Ranitidine Hydrochloride Injection major impurities Identification of positioning its raw materials and injection in the quality control of the production process provides a test basis. This work includes the following four parts: a, RP-HPLC method for the determination of ranitidine hydrochloride content of raw materials and related substances existing Chinese Pharmacopoeia method using a gradient elution HPLC ranitidine hydrochloride ingredients and related substances. In this paper, Column: Diamonsial @ C18 (150mm-4.6mm, 5μm); mobile phase: methanol-5m mo1.L-1 ammonium acetate (0.06% sodium heptane, triethylamine adjusted to pH 7.0) (68: 32); column temperature: 30 ℃, flow rate of 1.0mL · min-1, detection wavelength 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 showed that in 20 ~ 400μg · mL-l range a good linear relationship. This method is more pharmacopoeia method is simple, fast. Two, RP-HPLC method for the determination of ranitidine hydrochloride injection and its related substances in this paper Column: Diamonsial @ C18 (150mm-4.6mm, 5μm); mobile phase: methanol a 5mmo1.L-1 ammonium acetate (0.06 % heptane sulfonate, triethylamine adjusted to pH 7.0) (68:32); column temperature: 30 ℃, flow rate of 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 showed that in 20 ~ 400 pg.mL-1 range a good linear relationship. Third, the use of ranitidine hydrochloride related substances HPLC-MS study of ranitidine hydrochloride acid at high temperatures and under conditions resulting destruction of the main related substances were analyzed for ranitidine hydrochloride acid damage and thermal damage, after the raw materials coexisting impurities separation preparation, utilization MS and NMR spectra of acid degradation products is 5 - (dimethylamino) methyl-2 - alcohol, thermal degradation products of N-2 [[[5 - [(dimethylamino- ) methyl] 2 - furanyl] methyl] thio] -2 - nitro-acetamide. Fourth, ranitidine hydrochloride injection related substances N-2 [[[5 - [(dimethylamino) methyl] 2 - furanyl] methyl] thio] -2 - nitro-acetamide positioning Identification HPLC research, ranitidine hydrochloride injection related substances N-2 [[[5 - [(dimethylamino) methyl] 2 - furanyl] methyl] thio] -2 - nitro-acetamide Identification of positioning using correction factors plus self-control method of principal component quantitative study was carried out for its raw materials and injection in the production process quality control provides a test basis.

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CLC: > Medicine, health > Pharmacy > Pharmacopoeia Codex ( formulary ),drug identification > Drug identification > Determination of drug content
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