Design of trio-colored validated HPLC method for synchronized multianalyte quantitation of four top selling antihyperlipidemic drugs in different fixed-dose combined tablets

Abstract

The ongoing attempts to attain the sustainable development goals, to save the environment, to embrace the novel paradigm of white analytical chemistry and to focus on the practicality of the technique are non-stoppable. In this consensus, we designed a rapid trio-colored (green, white and blue) analytical methodology for the simultaneous estimation of Ezetimibe (EZT), Atorvastatin (ATV), Rosuvastatin (RSV) and Simvastatin (SMV). The suggested method was HPLC-DAD employing Microsorb MV-C18 column (4.6 × 250 mm, 5 μm particle size). The mobile phase composed of 0.1 % ortho-phosphoric acid and acetonitrile eluted in a gradient mode. Diode array detector was adjusted at 237 and 243 nm. Separation was fulfilled in less than 9 min and the retention times were 3.48, 4.32, 4.73 and 8.74 min for RSV, EZT, ATV and SMV respectively. The 4 drugs were quantitatively measured in the concentration range 1–50 μg/mL. In addition to validation according to the ICH guides, the greenness assessment using the novel AGREE calculator and the holistic overall evaluation applying the RGB-12 model in addition to the practicality check using the Blue Applicability Grade Index (BAGI) were performed. The results proved the efficiency and whiteness of the suggested technique to be routinely involved in quality control laboratories for assay of these drugs in their binary mixtures combination pills.

Keywords

• Ezetimibe
• Atorvastatin
• Rosuvastatin
• Simvastatin
• HPLC
• whiteness/greenness/blueness evaluation