UHPLC-DAD Method Development and Validation: Degradation Kinetic, Stress Studies of Farnesol and Characterization of Degradation Products Using LC-QTOF-ESI-MS with in silico Pharmacokinetics and Toxicity Predictions

Author:

Moinuddin Shaik Khaja1,Gajbhiye Rahul L2,Mehta Pakhuri3,Sarmah Bhaskar14,Murty Upadhyayula Suryanarayana5,Ravichandiran V6,Samudrala Pavan Kumar7,Alexander Amit8,Kumar Pramod1ORCID

Affiliation:

1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, Guwahati, SilaKatamur (Halugurisuk), Changsari, Kamrup, Assam 781101, India

2. Central Instrumentation Facility, National Institute of Pharmaceutical Education and Research, Chunilal Bhawan (Adjacent to BCPL), 168, Maniktala Main Road, P.O. Bengal Chemicals, P.S. Phoolbagan, Kolkata, West Bengal 700054, India

3. Faculty of Chemistry, Biological and Chemical Research Centre, University of Warsaw, Warsaw 02-093, Poland

4. BioNEST, Incubation Centre, National Institute of Pharmaceutical Education and Research (NIPER-Guwahati), Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India, Sila Katamur (Halugurisuk), Changsari, Kamrup, Guwahati, Assam 781101, India

5. National Institute of Pharmaceutical Education and Research, Guwahati, SilaKatamur (Halugurisuk), Changsari, Kamrup, Assam 781101, India

6. National Institute of Pharmaceutical Education and Research, Chunilal Bhawan (Adjacent to BCPL), 168, Maniktala Main Road, P.O. Bengal Chemicals, P.S. Phoolbagan, Kolkata, West Bengal 700054, India

7. Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER)-Guwahati, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India, Sila Katamur (Halugurisuk), Changsari, Kamrup, Guwahati, Assam 781101, India

8. Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER)-Guwahati, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India, Sila Katamur (Halugurisuk), Changsari, Kamrup, Guwahati, Assam 781101, India

Abstract

Abstract Farnesol (FAR) is a sesquiterpene molecule with high lipophilicity that has antibacterial and other pharmacological properties along with broad nutritional values with high commercial values. Although having potential, FAR stability behavior and degradation kinetics are not available in the literature. Hence, it is very essential to develop a simple, rapid, accurate, precise, robust, cheap UHPLC-DAD method for FAR. It was also proposed to study mechanistic insights into FAR under different degradation conditions. Therefore, we hypothesized to do systematic stability studies along with degradation kinetic and accelerated stability studies. The developed method was validated. FAR was studied for stress studies, degradation kinetics and ADMET prediction of degradants. Degradation products were characterized using LC-QTOF-ESI-MS. Developed method consists of an isocratic mobile phase with a wavelength of 215 nm. The percent recoveries for FAR were observed within the acceptance limit of 98–102%. The eight major degradation products were formed during stress studies. FAR follows first-order degradation kinetics. FAR and all degradants were found to have more than 75% good human oral absorption, and are non-toxic. FAR UHPLC-DAD method was developed, validated and performed stability studies to know the possible degradation pattern along with degradation kinetic studies.

Publisher

Oxford University Press (OUP)

Subject

General Medicine,Analytical Chemistry

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