Method for simultaneously detecting levorotatory lansoprazole and dextrorotatory lansoprazole in human plasma by HPLC-MS/MS combination

Abstract

The invention relates to a method for simultaneously detecting levorotatory lansoprazole and dextrorotatory lansoprazole in human plasma by HPLC-MS / MS combination. The method comprises the following steps of (1) pretreating a human plasma sample, (2) carrying out liquid chromatography-mass spectrometry detection, and (3) determining the L-lansoprazole and the D-lansoprazole in the human plasma. By adopting the detection method provided by the invention, when the plasma sample is pretreated, esomeprazole is used as an internal standard, IC is used as a chromatographic column for gradient elution, L-lansoprazole and D-lansoprazole can be directly separated, the sample preparation is simple, the analysis time is short, the requirement on detection equipment is low, and the method has the advantages of small amount of plasma required for detection, good repeatability, high sensitivity, high analysis speed, small matrix effect influence and the like, and can be used for evaluating safe use of drugs and consistency evaluation of dexlansoprazole for injection.

Description

technical field [0001] The invention belongs to the field of biological analysis, and in particular relates to a method for simultaneously detecting L-lansoprazole and D-lansoprazole in human plasma by using HPLC-MS / MS. Background technique [0002] Lansoprazole is a proton pump inhibitor. Proton pump inhibitors are benzimidazole derivatives that specifically and non-competitively act on H+ / K+-ATPase to treat peptic ulcer. Most proton pump inhibitors are fat-soluble and weakly alkaline. After being absorbed into the blood, they enter the acidic environment of the parietal cell secretory tubules and tubule vesicles. The activated products are generally active sulfenic acid and sulfenamide, which interact with H+-K+-ATPase Sulfhydryl coupling forms an irreversible covalent disulfide bond, blocks the H+-K+ transport mechanism, thereby inhibiting gastric acid secretion, and is mainly used for digestion of gastric ulcer, duodenal ulcer, reflux esophagitis, gastrinoma, etc. For ...

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Problems solved by technology

[0003] Chinese patent CN 111337615A discloses LC-MS technology to simultaneously detect omeprazole, rabeprazole, lansoprazole and pantoprazole in human plasma The concentration of enantiomers, disclosed in this patent, adopts isocratic elution to simultaneously measure the concentration of L-lansoprazole and D-lansoprazole in human plasma, the analysis time is 10min, the analysis time is longer, and the requirements for detection equipment are high , not suitable for the detection requirements of large batches of biological samples; when preparing the working solution, the solvent used is acetonitrile containing 0.1% ammonia water, because the ammonia water has a pungent smell and is also volatile, which brings a lot of pain to the experimental operators during the detection process. It is harmful and interferes with the accuracy of the measurement results

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