Green Analytical Method Development and Validation of Deflazacort by RP and NP HPTLC Methods and by RP-HPLC

Abstract

Based on Chromatographic separation, two eco-friendly techniques were developed for Deflazacort. Deflazacort (DFZ) is an oxazoline derivative that is used as a first-line medication for Duchene Muscular Dystrophy (DMD), a progressive X-linked disorder that affects mainly skeletal and Cardiac muscle. The Green Analytical Chemistry approach was incorporated for the development of analytical methods. The first method was High- Performance Thin Layer Chromatography (HPTLC). Both RP and NP-HPTLC methods were green and sustainable for Deflazacort and it was detected at wavelength 244 nm. The green mobile phase optimized was Iso-propanol: water: acetic acid (50:50:2% v/v/v) and N-propanol: ethyl acetate: acetic acid (95:5:2% v/v/v) for G-RP-HPTLC and G-NPHPTLC, respectively. Here, Rf values were 0.46 and 0.76 for the reverse and normal phases respectively. The linearity range was 500-2500 ng/band and 400-1000 ng/band for reverse and normal phases, respectively. The second method was High Performance Liquid Chromatography (RP-HPLC) with UV as a detector for quantification of a drug at wavelength 244 nm over a linearity range of 10-60 ppm with for Deflazacort. The green mobile phase optimized was Iso-propanol: water: acetic acid (60:40:0.2% v/v/v) for G-RPHPLC. Both techniques were evaluated for greenness assessment using AGREE tool and the green values for RP and NP HPTLC were found to be 0.92 and 0.87, respectively, and for RP-HPLC it was 0.85 suggesting an excellent greenness profile. According to the greenness score, the G-RP-HPTLC method is greener than G-NP-HPTLC by comparing the values. Both methods are simple, accurate, precise, specific, and green for the estimation of deflazacort in bulk and pharmaceutical dosage forms.