Method development and validation of Atorvastatin, Ezetimibe and Fenofibrate using RP-HPLC along with their forced degradation studies and greenness profiling

Abstract

ABSTRACT The present study aimed to separate the three-drug combination and degradant products by applying stress studies in bulk and pharmaceutical using RP-HPLC green analytical chemistry principles to make the separation better and more effective without compromising the standard limits. The three drugs have separated using the Mobile Phase Mixture of 10 volumes of buffer (0.1% triethanolamine in water) and 90 volumes of ethanol on the stationary phase Inertsil ODS 3 (250 mm x 4.6 mm), 5 µm column, at a wavelength of 256 nm. The method has been performed on a linear concentration range of 12–28 µg/mL for ATR, EZB, and 192- 448 µg/mL for FNF. The forced degradation studies showed that the ATR had > 5% degradation in acid, peroxide and thermal degradation, as EZB tends to degrade more than 15% at alkali hydrolysis. Moreover, the methodology has been validated according to ICH Q2 R1 guidelines, assessed using green evaluation tools like GAPI, AES, and AGREE, and found eco-friendly according to the output of the greenness outcomes. The developed method employed for determining three drugs has shown within limits according to the guidelines, easily adaptable by the pharmaceutical industries for their regular quality control analysis of the combinations. GRAPHICAL ABSTRACT