Analytical Tools for Greenness Assessment of Chromatographic Approaches: Application to Pharmaceutical Combinations of Indapamide, Perindopril and Amlodipine

Abstract The green profile of the proposed method was assessed and compared with reported classical methods via four tools of greenness which are: Eco-Scale, National Environmental Methods Index (NEMI), Assessment of Green Profile (AGP) and Green Analytical Procedure Index (GAPI). A simple, precise and rapid (RP-HPLC) has been developed for the quantification of Indapamide (IND), perindopril (PER) arginine and amlodipine besylate (ADB) in binary and ternary mixtures. A greener alternate RP-HPLC method was presented for the determination of pharmaceutical combinations composed of the cited medications using an eco-friendly eluent and quick run time with the least waste yield. Chromatographic separation was achieved using Waters Spherisorb ODS-2 C18 column (150 x 4.6 mm, i.d., 5 μm) and eluent formed of acetonitrile : phosphate buffer (20 mM, pH= 3): methanol in the ratio of (65: 30: 5, by volume) at flow rate 1.0 mL/min with DAD-detection at 220 nm. This procedure was valid over linearity ranges of 0.5-20 μg/mL, 2.5-40 μg/mL and 2-40 μg/mL for IND, PER and AML, respectively. The presented chromatographic method was completely validated regarding ICH guidelines and were statistically compared with those of the reported methods applying t-test and F-test at 95% confidence. The proposed method was found to be greener in terms of usage of hazardous chemicals and solvents, energy consumption, and waste production.