The implementation of the new edition of the Pharmacopoeia promotes the development of the liquid chromatograph industry

[ Policies and Regulations of Chemical Machinery Equipment Network ] The three new editions of the Pharmacopoeia highlight the national standards and conformity of biological products.
Among them, the detection of chemical impurities has been revised and increased to a large extent compared with the 2015 edition.
The industry believes that in this context, strengthening drug impurity analysis and testing and controlling the impurity content in drugs have become a major issue for pharmaceutical companies, and the entire pharmaceutical industry and related companies will be affected.
At the same time, in order to meet the requirements of the new regulations, relevant companies may expand their demand for high-performance liquid chromatography and other testing equipment.

High-performance liquid chromatography (HPLC) is an instrument that applies the principles of high-performance liquid chromatography and is mainly used to analyze organic compounds with high boiling point, non-volatile, thermally unstable, and large molecular weight.
It consists of a reservoir, pump, sample injector, chromatographic column, detector, recorder and other parts.
The mobile phase in the reservoir is pumped into the system by the high-pressure pump, and the sample solution enters the mobile phase through the sampler, and is loaded into the chromatographic column (stationary phase) by the mobile phase.
With different distribution coefficients, when the two phases move relative to each other, after repeated adsorption-desorption distribution processes, each component has a large difference in moving speed, and is separated into individual components and flows out of the column in turn When passing through the detector, the sample concentration is converted into an electrical signal and sent to the recorder, and the data is printed out in the form of a map.
HPLC is widely used in life sciences, food sciences, pharmaceutical research, and environmental research.

High performance liquid chromatography only requires that the sample can be made into a solution, and is not limited by the volatility of the sample.
The mobile phase can be selected in a wide range, and there are many types of stationary phases.
Therefore, it can separate thermally unstable and non-volatile, dissociated and Non-dissociated and various molecular weight ranges.

In conjunction with sample pretreatment technology, the high resolution and high sensitivity achieved by HPLC make it possible to separate and simultaneously determine substances with very similar properties, and to separate trace components in complex phases.
With the development of the stationary phase, it is possible to complete its separation under the condition of fully maintaining the activity of biochemical substances.

 

　　HPLC has become the most promising method to solve the problem of biochemical analysis.
Because HPLC has the advantages of high resolution, high sensitivity, fast speed, reusable chromatographic column and easy collection of effluent components, it is widely used in various fields such as biochemistry, food analysis, medical research, environmental analysis, inorganic analysis, etc.
.
The combination of high performance liquid chromatography and structural instruments is an important development direction.  

　　Liquid chromatography-mass spectrometry technology has received widespread attention, such as the analysis of carbamate pesticides and polynuclear aromatic hydrocarbons, etc.
; liquid chromatography-infrared spectroscopy has also developed rapidly, such as the determination of hydrocarbons in water and seawater in environmental pollution analysis The non-volatile hydrocarbons have made new developments in environmental pollution analysis.

 

　　Source: Encyclopedia
 

　　Original title: The implementation of the new pharmacopoeia promotes the development of the liquid chromatograph industry