Greenness, Whiteness, and Blueness Assessment With a Novel and Fully Validated HPLC Method for Simultaneous Analysis of Lumacaftor and Ivacaftor in Sweat.

Sweat is an alternative biological fluid to plasma, urine, hair, and saliva, and it is promising for various pharmaceutical research types. Excessive sweating is one of the symptoms of cystic fibrosis, a hereditary disease. In this study, an easy, simple, applicable, and economical HPLC method was proposed for sweat analysis of the lumacaftor/ivacaftor combination used in the treatment of the disease. The solvent for the method was selected using the Green Solvent Selection Tool (GSST). The mobile phase was gradient elution mode and contained a mixture of 0.1% formic acid in acetonitrile (v/v) and 0.1% formic acid in water (v/v). Analytes were detected at a wavelength of 220 nm. LOD values for LUMA and IVA are 3.16 and 0.92 μg/mL, respectively. The linearity range was 60-150 μg/mL for both analytes, and matrix-matched calibration was performed. The greenness was evaluated with AGREE and ComplexGAPI, the whiteness with the red-green-blue 12 (RGB 12) algorithm, and the blueness with the Blue Applicability Degree Index (BAGI). The AGREE score of the method was calculated as 0.72, the BAGI score as 87.5, and the RGB 12 algorithm as 88.3. As a result, the method was presented to researchers as a sustainable, green, and efficient method.