Near infrared spectrum online detection method of etimicin sulfate column separation process

Abstract

The invention discloses a near infrared spectrum online detection method of etimicin sulfate column separation process. The method of the invention comprises the following steps: (1) collecting different batches of eluant samples during the etimicin sulfate column separation process; (2) measuring contents of etimicin sulfate, C1a component and the like in the eluant samples by liquid chromatography or ion chromatography; (3) acquiring near infrared spectral data of the eluant samples; (4) establishing a key index rapid analysis model; and (5) rapidly measuring etimicin sulfate in unknown eluant samples, C1a component and liquid-phase total peak area. The near infrared spectroscopy technology is applied to the etimicin sulfate column separation process. In comparison with a traditional liquid phase and gas phase chromatography, the established analysis method of the invention is rapid and effective, can be used for rapidly measuring etimicin sulfate, C1a component and total matter quantity during the etimicin sulfate column separation process, and is suitable for real-time analysis and online monitoring during the production process of etimicin sulfate.

Description

technical field [0001] The invention belongs to the field of near-infrared detection, and in particular relates to an online near-infrared spectrum detection method in the column separation process of etimicin sulfate. Background technique [0002] Etimicin sulfate is the latest generation of aminoglycoside antibiotics, and it is also the only national first-class new drug of antibiotics with independent intellectual property rights since the founding of the People's Republic of China. This product is an important drug for the treatment of Gram-negative bacterial infections and drug-resistant pathogenic bacteria infections. Clinical results show that etimicin sulfate has good curative effect on bacterial infection and low incidence of adverse reactions. It is a safe and effective new variety of aminoglycoside antibiotics developed in recent years, and has played an important role in the prevention and treatment of infectious diseases. [0003] As a fast and non-destructive ...

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Problems solved by technology

[0004] In the field of drug quality control and production application, the application of near-infrared spectroscopy technology to the detection of key indicators in the process of raw medicinal materials, chemical drug separation, finished products, distillation, concentration, alcohol precipitation, and chromatography has related patent documents, such as patent (patent Application No.: 200510130631.6, 200810050095.2, 201010125515.6, 200910228468.5, 201010577454.7), etc. However, there are no relevant reports on the use of near-infrared spectroscopy for the determination of key indicators in the separation process of etimicin sulfate column

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