New Chromatographic Techniques for Sensitive Mebendazole Quantification in the Presence of Degraded Product, Commercial Tablets Application, and Greenness Assessment

Abstract

Background: Before it spreads to other tissues, mebendazole (MBZ), a highly effective broad-spectrum anthelmintic, is used to treat worm infestations caused by roundworms, hookworms, whipworms, threadworms (pinworms), and the gastrointestinal form of trichinosis.

Objective: The development of new methods for sensitive quantification of MBZ in the presence of its degraded product is the main objective of the presented research.

Method: Validated chromatographic techniques with high sensitivity (HPTLC and UHPLC) are used. The HPTLC method was adopted on silica gel HPTLC F254 plates using ethanol, ethyl acetate, and formic acid (3: 8: 0.05, by volume) as a developing system. Furthermore, the UHPLC method is a green isocratic method with a mobile phase containing methanol and 0.1% sodium lauryl sulphate (20:80, v/v).

Results: The suggested chromatographic methods are greener than the reported ones in terms of the used greenness assessment methods. To validate the developed methods, International Council on Harmonization (ICH/Q2) guidelines were followed. Successful application of the proposed methods was revealed by the simultaneous analysis of MBZ and its major degradation product, 2-amino-5-benzoylbenzimidazole (ABB). The linear ranges were 0.2-3.0, 0.1-2.0 µg/band for the HPTLC method and 2.0-50, 1.0-40 µg/mL for the UHPLC method for MEB and ABB, respectively.

Conclusions: The suggested methods were used to analyze the studied drug in its commercial tablets. Both pharmacokinetic studies and quality control laboratories can make use of the suggested techniques.

Highlights: Green and accurate HPTLC and UHPLC methods for the determination of MBZ and its major degradation products.