[Development of selective method for identifying mebeverine in hair].

Abstract

Objective: To develop the method for identification of mebeverine and its metabolites in biological materials (urine and hair) for solution of the problem of possible cross-reaction with psychoactive substances during preliminary studies by immunochromatographic method.

Material and methods: The study was carried out using «Mebeverine» tablets (NAO «Severnaya Zvezda», Russia), enzymes, namely trypsin, chymotrypsin and hyaluronidase, papain. The obtained extracts were analyzed using HELC-MS/MS on a modular liquid Nexera XR chromatograph with a tandem LCMS-8050 (Shimadzu) mass spectrometer. Guinea pigs weighing about 500 gr were used in modelling the long-term use of mebeverine. The drug was administered per os, once to 5 guinea pigs at a dosage of 200 mg calculated as an animal weighing 500 gr and daily urine was collected. The wool was collected 30 days after regular administration.

Results and conclusion: The main mebeverine's metabolites have been determined and native mebeverine and its marker metabolites (mebeverine and veratric acids) have been found in urine while taking this medicine in therapeutic doses for medical purposes. The application of enzymatic hydrolysis of hair method allowed to establish that hair tissue accumulates only a native molecule of mebeverine, therefore, only by results of hair analysis it is possible to conclude, if there was pharmacological use of this medicine or psychoactive substances from the group of phenylalkilamines. The effectiveness of enzymatic hydrolysis by hyaluronidase to isolate mebeverine from hair has been shown.