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

Author:

Ahmed Amal B1ORCID,Batakoushy Hany A2ORCID,Abdallah Fatma F3ORCID

Affiliation:

1. Nahda University, Faculty of Pharmacy, Pharmaceutical Chemistry Department , Beni-Suef 62514, Egypt

2. Menoufia University, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry , Shebin Elkom 32511, Egypt

3. Beni-Suef University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department , Alshaheed Shehata Ahmad Hegazy St , Beni-Suef 62514, Egypt

Abstract

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.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry

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