Application of Gas Chromatography-Mass Spectrometry in Pharmaceutical Analysis

Gas-mass spectrometry is the main and basic research method and method in the field of pharmaceutical analysis, and it is developing very rapidly. Gas chromatography ( GC ) is an increasingly widely used analytical technique in recent years. It is especially suitable for the separation and analysis of complex components with volatility. Because of the gas as the mobile phase, the mass transfer rate is fast. The sample analysis can be completed in about 20-30s. It has the characteristics of high separation efficiency and high sensitivity. It can be used for qualitative and quantitative analysis under the condition of reference substance, but it can not make a positive identification report for major events or controversial samples. A detector such as a mass spectrometer must be connected. In addition, samples that cannot be gasified need to be derivatized and then analyzed.
Mass Spectrnum (MS) is a powerful structural analysis tool that provides more information for structural characterization and is an ideal chromatographic detector.
Gas-mass spectrometry (GC-MS) has greatly promoted the development of drug analysis, especially in the determination of substances, substance testing, quality standard setting, component analysis, and metabolite analysis of pharmacokinetic studies. And in the test of the concentration distribution of metabolites in vivo, it has become a powerful analytical tool. Due to the high separation capacity of the chromatogram and the high discrimination characteristics of the mass spectrometer, it is a perfect modern analysis method for the separation, qualitative and quantitative analysis of complex mixed samples. This paper reviews the application examples of gas-mass spectrometry in the above fields in recent years.
Second, in the application of pharmacokinetics, drug metabolite research In 2004, Zhang Yinong and other studies on the metabolites of the steroidal drug 7-methyl norethrelone (Tibolone) urine, using GC-MS selective ion monitoring (SIM Three kinds of metabolites, △4 double bond isomer, 3α hydroxy group and 3β hydroxy group, were found. The concentration-time curve of 3α hydroxy metabolite was determined, indicating that Tibolone absorbed quickly after oral administration, and peak concentration was obtained after 9 hours. . The research team used GC-MS to study the new stimulant masking drug hydroxyethyl starch. According to the retention time and characteristic ions, hydroxyethyl monomer and 2-hydroxyl were detected in the urine of the subject. Three metabolites such as ethyl monomer and 6-hydroxyethyl monomer.
In 2003, Chen Jiangang and other solid phase microextraction-gas/mass spectrometry were used to determine heroin metabolites in urine. Experimental conditions: DB-l capillary column (30 m × 0.25 mm × 0.25 μm); programmed temperature: initial temperature: 120 ° C (2 min), 20 ° C / min rose to 280 ° C (8 min); He flow rate 1.0 mL / min; inlet temperature 250 ° C; interface temperature 280 ° C; no split injection 3 min; solvent delay 2 min. The mass spectrum scanning range is 50-400 U, the scanning rate is 0.5 S, and the multiplier voltage is 1.1 kV. The mass spectrometry was characterized by full scan mode (SCAN) and the quantitation was performed using selective ion mode (SIM).
Throughout the partial application of the above gas-mass spectrometry in new drug research, it can be seen that whether it is content determination, related substance inspection, quality standard formulation and other new drug quality research, or pharmacokinetic study in blood drug concentration determination, metabolism Pathway analysis, metabolite identification, etc., all belong to less content and more interference, requiring high sensitivity, good selectivity, fast and accurate analysis methods. With the expansion of the scope of application and the deepening of new drug research, gas-mass spectrometry has been raised from simply providing data to obtaining useful information and factors from data and maps to solve practical problems in new drug research, along with electronics. Computers and instrumentation are constantly being upgraded, and gas-mass spectrometry is becoming more widely used. The gas-mass spectrometry usage of the 21st century will still show its vitality.

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