Simultaneous analysis of fenofibrate and rosuvastatin in commercial fixed-dose combination tablets using the green HPTLC method
Abstract
Abstract This work develops and validates a green reverse-phase “high-performance thin-layer chromatography (HPTLC)” methodology for measuring fenofibrate (FEN) and rosuvastatin (ROS) concurrently in commercially available fixed-dose combination (FDC) tablets. A green developing system comprising ethanol, water, and ammonia solution (25 % for HPLC) in a 65:30:5 (v/v/v) ternary ratio was used to analyze FEN and ROS concurrently. At a wavelength of 265 nm, FEN and ROS were both concurrently measured. The method’s greenness profile was evaluated using three different greenness methodologies: the analytical eco-scale (AES), chloroform toxicity (ChlorTox), and the analytical GREEnness (AGREE). The developed method was linear for both drugs in the 20–1,200 ng/band range. The developed method was validated and shown to be reliable, sensitive, accurate, precise, and eco-friendly. The results of every greenness tool, such as AES (87), ChlorTox (0.78 g), and AGREE (0.78) demonstrated that the proposed method had an exceptionally greenness profile. The levels of FEN and ROS in two different marketed FDC products were found to be within the 100 ± 2 % limit using the current methodology. The study’s findings demonstrated that the suggested technique could reliably evaluate FEN and ROS in commercially available products.
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