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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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 |
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