Method for detecting related substances in rapamycin drug stent
The invention discloses a method for detecting related substances in a rapamycin drug stent. The method comprises the following steps: detecting by adopting a high performance liquid chromatography to obtain a specific chromatogram of the related substances; the chromatographic conditions of the hig...
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Zusammenfassung: | The invention discloses a method for detecting related substances in a rapamycin drug stent. The method comprises the following steps: detecting by adopting a high performance liquid chromatography to obtain a specific chromatogram of the related substances; the chromatographic conditions of the high performance liquid chromatography are as follows: a sodium citrate aqueous solution with the volume concentration of 8-12 mM is taken as a mobile phase A, acetonitrile is taken as a mobile phase B, elution is performed according to the following gradient elution procedure, and the detection wavelength is 278 nm. According to the detection method provided by the invention, the peak pattern symmetry of rapamycin chromatographic peaks and the separation degree among impurities are improved, the accuracy and repeatability of quantification of related substances are improved, and the control of the related substances in a product is facilitated.
本发明公开了一种雷帕霉素药物支架中有关物质的检测方法,包括采用高效液相色谱法检测获得有关物质的特征图谱;所述高效液相色谱法的色谱条件为:以体积浓度 |
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