Metformin hydrochloride and quality detection method of preparation of metformin hydrochloride

The invention relates to the field of drug detection, in particular to metformin hydrochloride and a quality detection method of a preparation of metformin hydrochloride. A high-performance liquid chromatography is adopted, sulfonic cation exchange bonded silica gel is adopted as a filler, an ammoni...

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Hauptverfasser: ZHAO TIECHAN, XIAO JIAPU, ZHANG TINGTING, WEI HUIFANG, SONG GENGSHEN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to the field of drug detection, in particular to metformin hydrochloride and a quality detection method of a preparation of metformin hydrochloride. A high-performance liquid chromatography is adopted, sulfonic cation exchange bonded silica gel is adopted as a filler, an ammonium dihydrogen phosphate solution is adopted as a mobile phase, and the pH value of the mobile phaseis 3.9-4.1. By optimizing the conditions above, metformin hydrochloride, an impurity A, an impurity B, an impurity C, an impurity D, and an impurity E are all effectively separated in a chromatogram,and the content of the components above in a test sample can be accurately quantified according to respective peak areas, so that the detection limit and quantitation limit of the substances above areoptimized. Meanwhile, a detection result is stable, the accuracy is high, the detection method is simple, easy to implement and convenient to popularize, the technical basis is provided for the quality control of metformin hyd