A New Ecological RP-HPLC Method for the Determination of Pitavastatin, Fenofibrate and Their Impurities in a Novel Fixed Dose Combination

We developed a simple, rapid, ecological RP-HPLC method for the estimation of Pitavastatin (PIT), Fenofibrate (FEN), and their impurities in a novel fixed dose combination. We achieved an efficient chromatographic separation in gradient elution mode using Hypersil BDS C18 (100 × 4.6 mm, 3.0 μm) column. The mobile phase A consisted of 0.1% glacial acetic acid buffer and mobile phase B consisted of ethanol and the flow rate was 1.7 mL per minute. We monitored the chromatogram at 250 nm detection wavelength and the column thermostat at 35 °C. The observed resolution for PIT, FEN, and 12 impurities is more than 1.5 for any pair of compounds. The proposed method was validated as per the ICH guidelines for precision, specificity, accuracy, linearity, robustness, ruggedness and it is efficient in estimating PIT, FEN, and their impurities in the same run. The drug product was subjected to various stress degradation conditions and observed a significant amount of degradation in hydrolytic and thermal degradation study. We estimated the method greenness using different Green Analytical Chemistry (GAC) metrics such as Analytical Eco-scale, scoring of hazardous values, Analytical Method Volume Intensity (AMVI), Environmental Assessment Tool (EAT), solvent selection guide approach, and Eco-solvent approach.