High performance liquid chromatography method for determining related substances in nicardipine hydrochloride bulk drug

The invention provides a high performance liquid chromatography for determining related substances in a nicardipine hydrochloride bulk drug, which adopts a chromatographic column with octadecylsilane chemically bonded silica as a filler, adopts a mobile phase A consisting of 3.5 g/L sodium perchlora...

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Hauptverfasser: ZHOU LINA, YANG YUNFEI, PU JUNHUA
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention provides a high performance liquid chromatography for determining related substances in a nicardipine hydrochloride bulk drug, which adopts a chromatographic column with octadecylsilane chemically bonded silica as a filler, adopts a mobile phase A consisting of 3.5 g/L sodium perchlorate monohydrate and a 1ml triethylamine-containing aqueous solution with the pH adjusted to 2.0 by perchloric acid and a mobile phase B consisting of acetonitrile-methanol (70: 30), gradient elution is carried out, and the content of the related substances in the nicardipine hydrochloride bulk drug is measured. According to the method, related substances including process impurities, forced degradation impurities and the like in the nicardipine hydrochloride raw material medicine can be effectively separated, a gradient elution method is adopted for analysis, and the method is good in reproducibility, high in specificity, high in sensitivity and easy and convenient to operate. 本发明提供了一种测定盐酸尼卡地平原料药中有关物质的高效液相色谱法,该方法采用十