Method for detecting related substances of compound calcium gluconate oral solution
The invention belongs to the technical field of biological medicine, and relates to monitoring of medicine quality, in particular to a method for detecting related substances of a compound calcium gluconate oral solution. Detection substances comprise 1, 4-glucolactone, 5-hydroxymethylfurfural, 5-hy...
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Sprache: | chi ; eng |
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Zusammenfassung: | The invention belongs to the technical field of biological medicine, and relates to monitoring of medicine quality, in particular to a method for detecting related substances of a compound calcium gluconate oral solution. Detection substances comprise 1, 4-glucolactone, 5-hydroxymethylfurfural, 5-hydroxymethyl furoic acid, calcium lactate and calcium gluconate, a monopotassium phosphate solution with the concentration being 18-50 mmol/L and the pH value being 1.9-2.3 is used as a mobile phase A, methyl alcohol is used as a mobile phase B, octadecylsilane chemically bonded silica is used as a filling agent of a chromatographic column, and the detection wavelength is 250nm. And performing high performance liquid chromatography detection on the compound calcium gluconate oral solution to be detected.
本发明属于生物医药技术领域,涉及药品质量的监控,具体涉及一种复方葡萄糖酸钙口服溶液有关物质的检测方法。检测的物质包括以1,4-葡萄糖酸内酯、5-羟甲基糠醛、5-羟甲基糠酸、乳酸钙、葡萄糖酸钙,以浓度为18~50mmol/L、pH为1.9~2.3的磷酸二氢钾溶液为流动相A,以甲醇作为流动相B,色谱柱的填充剂为十八烷基硅烷键合硅胶,对待测复方葡萄糖酸钙口服溶液进行高效液相色谱检测。 |
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