Method for determining cefoperazone sodium and sulbactam sodium related substances for injection

Abstract

The invention discloses a method for determining cefoperazone sodium and sulbactam sodium related substances for injection. The method comprises the following steps: preparing a solution by using solution preparation equipment, adding cefoperazone sodium and sulbactam sodium powder into a mixing tank through a feeding hopper, introducing water into the mixing tank, closing the feeding hopper, andstarting a driving mechanism and a heating mechanism. According to the method for determining the cefoperazone sodium and sulbactam sodium related substances for injection, the cefoperazone sodium andsulbactam sodium powder can be rapidly dissolved through forward and reverse rotation of a stirring frame I and a stirring frame II in the mixing tank, the temperature of the solution is increased bythe heating mechanism, and the dissolving efficiency of medicine powder is further improved; the dissolving effect of the cefoperazone sodium and sulbactam sodium powder is effectively improved, 14 impurities in the cefoperazone sodium and sulbactam sodium for injection can be effectively separated and quantitatively determined by adopting a newly established RPHPLC method, the system applicability of chromatography is high, the product quality can be more effectively controlled, and safe popularization and application are facilitated.

Description

technical field [0001] The invention relates to the technical field of drug determination, in particular to a method for determining related substances of cefoperazone sodium and sulbactam sodium for injection. Background technique [0002] Cefoperazone sodium and sulbactam sodium for injection is a compound preparation of cephalosporin and lactamase inhibitors. Cefoperazone sodium has a β-lactam structure, and sulbactam is a semi-synthetic β-lactamase inhibitor. Combined with cefoperazone sodium, it can enhance Bacteriostatic effect and antibacterial spectrum. It can be used to treat respiratory tract infection, urinary tract infection, peritonitis, cholecystitis, cholangitis and other intra-abdominal infection, sepsis, meningitis, skin and soft tissue infection, bone and joint infection, pelvic inflammatory disease and other reproductive system infection caused by sensitive bacteria. [0003] In the determination of related substances of cefoperazone sodium and sulbactam ...

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Problems solved by technology

[0005] Aiming at the deficiencies in the prior art, the present invention provides a method for determining related substances of cefoperazone sodium and sulbactam sodium for injection. The stirring assembly is driven to rotate in the mixing tank by the driving mechanism, and the stirring frame one and the stirring frame two are carried out in the mixing tank. Forward and reverse rotation can quickly dissolve the cefoperazone sodium sulbactam sodium powder, and then increase the temperature of the solution through the heating mechanism to further accelerate the dissolution efficiency of the cefoperazone sodium sulbactam sodium powder, and can effectively improve the cefoperazone sodium sulbactam sodium powder. The dissolving effect of the powder solves the problem of adding cefoperazone sodium sulbactam sodium into a beaker for dissolution by artificial means when determining related substances of cefoperazone sodium sulbactam sodium. It is relatively low, and the dissolution effect is poor, which will adversely affect the determination of related substances of cefoperazone sodium and sulbactam sodium

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