Method for detecting biapenem and/or related substances

• Main Authors: DING YING, QIN FENG, ZHANG HANZHI, LIU HAO, ZHAO JINGDAN
• Format: Patent
• Language: Chinese; English
• Published: 24.03.2020
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention relates to a method for detecting biapenem and/or related substances, which is a normal phase chromatography and adopts a mobile phase consisting of an organic solvent and a buffer saline solution for isocratic elution. The related substance is at least one of a biapenem parent nucleus, a side chain, a biapenem condensation compound, a ring-opening compound, a dimer A, a dimer B anda biapenem carbamyl ring-opening compound; the organic solvent is acetonitrile or a methanol-acetonitrile mixed solution; the buffer salt is at least one of sodium salt, potassium salt and ammonium salt of phosphoric acid, acetic acid or formic acid. The detection method disclosed by the invention is simple, convenient and rapid to operate, can be used for efficiently, rapidly and accurately determining the contents of effective substances and specific various impurities in the biapenem medicine, and can provide a technical basis for evaluating a biapenem production process or product quality,storing a preparation and