Method for separating and measuring bepotastine besilate and potential genotoxic impurities thereof with HPLC (High Performance Liquid Chromatography) method

Abstract

The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring bepotastine besilate and potential genotoxic impurities thereof with a HPLC (High Performance Liquid Chromatography) method. According to the method, an adopted chromatographic column is characterized in that octadecylsilane chemically bonded silica is taken as a filler, a flowing phase A and a flowing phase B are adopted for performing gradient elution, and enter a detector for detecting; the potential genotoxic impurities includes ethyl benzenesulfonate and isopropyl benz-enesulfonate; the flowing phase A is a phosphoric acid solution, and the flowing phase B is an acidic acetonitrile solution. By adopting the method, the contents of the bepotastine besilate and the potential genotoxic impurities thereof can be effectively separated and measured; high sensitivity, specificity and repeatability are achieved; the measurement is not interfered by a solvent peak during detection, and a detection result is accurate and reliable, so that the method has an extremely important significance in realizing quality control for the bepotastine besilate and a preparation thereof.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring bepotastine besilate and its potential genotoxic impurities by HPLC. Background technique [0002] Bepotastine is a non-sedating, highly selective histamine (H1) receptor inhibitor, which has a highly selective inhibitory effect on histamine H1 receptors, has no affinity for 5-HT2, α1, α2, and has no affinity for 5-HT2, α1, α2. Mast cells have a stabilizing effect, can inhibit the infiltration of eosinophils into the inflammatory site during allergic inflammation, and can inhibit the activation of eosinophils interleukin-5 (IL-5), leukotriene B4 (LTB4) and platelets Activating factor (PAF), reduces allergic inflammation. Pharmacodynamic tests show that: bepotastine can inhibit the skin reaction caused by histamine; in vitro tests can inhibit the contraction of guinea pig isolated smooth muscle caused by histamine, inhibit the ...

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Problems solved by technology

[0006] So far, no published method has been reported for the efficient separation

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