Method for quantitatively detecting levo-lansoprazole and dextro-lansoprazole in biological sample by means of ultra-high performance convergence chromatography-mass spectrometry

Abstract

The invention provides a method for quantitatively detecting the levo-pantoprazole and the dextro-pantoprazole in a biological sample by means of ultra-high performance convergence chromatography-massspectrometry. According to the method, after the biological sample to be detected is subjected to pretreatment, the liquid to be detected is subjected to the ultra-high performance convergence chromatography-mass spectrometry detection; according to the peak area and the standard curve of levo-lansoprazole/dextro-lansoprazole and an internal standard in a detection spectrum, the concentration ofthe levo-lansoprazole and the dextro-lansoprazole in the biological sample to be detected is calculated through an internal standard method; the invention combines the ultra-high performance convergence chromatography (UPCC) with a triple quadrupole mass spectrometry (MS/MS) for quantitative detection of chiral drugs in biological samples for the first time; and the method provided by the invention is high in sensitivity, can meet the separation of chiral drugs in biological samples with low sample volume, low content, and complex matrix, and is short in detection time and low in cost.

Description

Technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for quantitatively detecting L-lansoprazole and dexlansoprazole in biological samples by ultra-efficient convergence chromatography-mass spectrometry. Background technique [0002] Chiral drugs (Stereoisomeric Drugs) refer to drugs containing chiral centers or asymmetric centers in the molecular structure, which include a single enantiomer and a mixture of two or more enantiomers. The physical and chemical properties of these enantiomers are basically similar, only the optical rotation is different. Studies have shown that about 60% of commonly used drugs have one or more chiral centers, and about 50% of the more than 2,000 commonly used drugs listed in the US Pharmacopoeia are chiral drugs. The chiral drug market is still expanding year by year, and chiral drugs have become an important direction for the research and development of new molecular entities. In the hum...

AI Technical Summary

Problems solved by technology

Among them, both GC and HPCE have the advantages of high efficiency and high sensitivity, but the scope of application is narrow

The advantage of HPLC is that it is the most widely used, does not require high temperature, and reduces isomerization, but it is usually separated in normal phase mode. The mobile phase is usually n-hexane and isopropanol or other normal phase solvents, and is not compatible with mass spectrometry.

SFC has the advantages of high separation efficiency of GC and HPCE and wide application range of HPLC, but it needs to be operated under high pressure, which requires high equipment and technology

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