Eco-Friendly Method Development and Validation for the Estimation of Fenofibrate and Atorvastatin in Marketed Formulation

Irshad Ali; BK Dubey; Deepak Kumar Basedia; Prabhat Kumar Jain; Sunil Shah; Vivek Singh Thakur

doi:10.24092/CRPS.2023.130402

Irshad Ali Technocrats Institute of Technology-Pharmacy, Bhopal (M.P.), India 462001
BK Dubey Technocrats Institute of Technology-Pharmacy, Bhopal (M.P.), India 462001
Deepak Kumar Basedia Technocrats Institute of Technology-Pharmacy, Bhopal (M.P.), India 462001
Prabhat Kumar Jain Technocrats Institute of Technology-Pharmacy, Bhopal (M.P.), India 462001
Sunil Shah TIT-College of Pharmacy, Bhopal (M.P.), India 462001
Vivek Singh Thakur TIT-College of Pharmacy, Bhopal (M.P.), India 462001

DOI https://doi.org/10.24092/CRPS.2023.130402

Abstract

This study focuses on the development and validation of an eco-friendly analytical method for the simultaneous estimation of Fenofibrate (FNF) and Atorvastatin (ATV) in a marketed formulation. The stability of both drugs was evaluated using a mixed hydrotropic solution of 2M Ammonium Acetate and 2M Sodium Citrate (1:1). This work focuses on the development and validation of an eco-friendly method for the simultaneous estimation of Fenofibrate and Atorvastatin in a marketed formulation. The stability of both drugs in a mixed hydrotropic solution was confirmed, and the method exhibited good linearity, recovery, and precision. The validated method was successfully applied to analyze a tablet formulation, demonstrating its applicability in routine quality control. The use of environmentally friendly practices in analytical methods contributes to sustainable pharmaceutical analysis.

Keywords: Eco-friendly method, Fenofibrate, Atorvastatin, Hydrotropic solution, Validation, Marketed formulation, Simultaneous estimation

References

1. Castiello C, Junghanns P, Mergel A, Jacob C, Ducho C, Valente S, Rotili D, Zwergel C, Mai A. GreenMedChem-the challenge in the next decade toward eco-friendly compounds and processes in drug design. Green Chemistry. 2023.
2. Becker J, Manske C, Randl S. Green chemistry and sustainability metrics in the pharmaceutical manufacturing sector. Current Opinion in Green and Sustainable Chemistry. 2022 Feb 1; 33:100562.
3. Ivanković A, Dronjić A, Bevanda AM, Talić S. Review of 12 principles of green chemistry in practice. International Journal of Sustainable and Green Energy. 2017 Jul 26;6(3):39-48.
4. Shaaban H. New insights into liquid chromatography for more eco-friendly analysis of pharmaceuticals. Analytical and bioanalytical chemistry. 2016 Oct; 408:6929-44.
5. Keith LH, Gron LU, Young JL. Green analytical methodologies. Chemical reviews. 2007 Jun 13;107(6):2695-708.
6. Elam MB, Ginsberg HN, Lovato LC, Corson M, Largay J, Leiter LA, Lopez C, O’Connor PJ, Sweeney ME, Weiss D, Friedewald WT. Association of fenofibrate therapy with long-term cardiovascular risk in statin-treated patients with type 2 diabetes. JAMA cardiology. 2017 Apr 1;2(4):370-80.
7. Abdelrahman MM, Emam RA, Ali NW, Abdelaleem EA. Novel eco-friendly chromatographic determinations of hydrocortisone acetate, fusidic acid, their pharmacologically active impurities and pharmaceutical excipients: a comparative study. Chemical Papers. 2020 Jul; 74:2175-87.
8. Walfish S. Analytical methods: a statistical perspective on the ICH Q2A and Q2B guidelines for validation of analytical methods. BioPharm International. 2006 Dec 1; 19(12):1-6.