High performance liquid chromatography method for detecting organic impurities in dibazol

Abstract

The invention belongs to the technical field of pharmaceutical analysis, and discloses a high performance liquid chromatography analysis method for detecting organic impurities in dibazol, a C18 chromatographic column is adopted, an ammonium acetate solution is used as a mobile phase A, glacial acetic acid is used for adjusting the ammonium acetate solution, the pH value of the ammonium acetate solution is adjusted to 5.5, acetonitrile is used as a mobile phase B, and gradient elution and ultraviolet detection are carried out. The method can be used for sensitively and accurately determining organic impurities in dibazol (or hydrochloride thereof), and has the advantages of convenience in operation, high separation degree of dibazol (chromatographic peak 1) and main impurities, stable base line, small interference and high sensitivity.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a high-performance liquid chromatography analysis method for detecting organic impurities in dimethazole. Background technique [0002] Dimethazole is a kind of drug, which is suitable for mild hypertension, or it can be used in combination with other antihypertensive drugs to treat hypertension. [0003] Dimethazole hydrochloride is the hydrochloride salt of 2-benzylbenzimidazole, which is included in the National Drug Standard WS1-24(B)-89-2010 of the State Food and Drug Administration, which does not stipulate the inspection of related substances. And this variety has not been included in foreign pharmacopoeia standards such as EP, USP and JP. [0004] Report on the prior art about the inspection of related substances of dibazole: Hu Defu, Tan Huijie and Jiang Hui, "Journal of Drug Analysis" 2004, 04, the detection method is: using Shimadzu C18 chromatograph...

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And this variety has not been included in foreign pharmacopoeia standards such as EP, USP and JP

[0004] Report on the prior art about the inspection of related substances of dibazole: Hu Defu, Tan Huijie and Jiang Hui, "Journal of Drug Analysis" 2004, 04, the detection method is: using Shimadzu C18 chromatographic column (4.6mm × 150mm, 5 μm); methanol-water -Triethylamine-glacial acetic acid (60:40:0.5:0.5) is the mobile phase; flow rate 1.0mL min-1; detection wavelength 272nm; Self-control method, no research on the detection limit and quantification limit of the known impurities that may exist, cannot guarantee that the method can effectively detect the known impurities that may exist, so it is impossible to scientifically and effectively detect the impurities in the finished product of dimethazole hydrochloride. Qualitative and quantitative inspections of relevant substances, so that it is impossible to give more comprehensive and instructive results in terms of safety, effectiveness and process control

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