High performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof

The invention relates to a high performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof. The invention relates to a method for determining related substances in minocycline hydrochloride, which comprises the following steps: preparing a test solution,...

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Hauptverfasser: WENG JING, ZHENG JINQI, YU YUQING, ZHU KUNDAN, CHEN CAIPING, CAO RUIWEI, ZENG HONGXIA, TAO QIAOFENG, WU PINPING, ZHOU QIAOLI
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to a high performance liquid chromatography detection method for minocycline hydrochloride and impurities thereof. The invention relates to a method for determining related substances in minocycline hydrochloride, which comprises the following steps: preparing a test solution, a reference solution, a system applicability solution, a sensitivity solution and a chromatographic column using octadecylsilane chemically bonded silica as a filler according to the specification of high performance liquid chromatography; an ammonium acetate solution-methanol mixed solution containing disodium ethylene diamine tetraacetate is taken as a mobile phase A, acetonitrile-methanol is taken as a mobile phase B, linear gradient elution is carried out, and the separation degree of minocycline peak and RS12 peak is not less than 1.5; and if an impurity peak corresponding to the relative retention time exists in the chromatogram of the test solution, calculating the percentage of the impurity according to an