Validated eco-friendly chromatographic methods for simultaneous determination of sacubitril and valsartan in spiked human plasma and in pharmaceutical formulation

Abstract

Two eco-friendly chromatographic approaches are developed for simultaneous quantification of Sacubitril (SAC) and Valsartan (VAL) in combined formulation. The first method depended on isocratic HPLC separation of the two medications on the reversed phase InertsiL ODS-3 column "C18 (5 μm, 150 mm x 4.0 mm, i.d.)" at ambient temperature utilizing a green mobile phase consisting of methanol: ethanol: water (40:30:30, by volumes) +0.1% triethyl amine, pH 3.5 with UV detection at 267 nm. Linearity was attained for both drugs at concentration ranges 1-300 μg.mL-1 in tablets formulation and 0.25-50 μg.mL-1 in spiked human plasma. Second method was HPTLC which based on separation of the two analytes with densitometric measurements of their resolved spots at 260 nm. Complete separation was performed on HPTLC plates (10 cm × 10 cm), 0.1 mm Nano silica gel with particle size 6-9 μm F254 (Merck) using ethyl acetate: methanol: glacial acid (9:1:0.1, by volumes) as a green mobile phase. The data of linear regression analysis was used for the regression line in concentration range of 1.5-4.5 and 0.8-4.5 μg.spot-1 for Sacubitril and Valsartan, respectively and 9-75 ng.spot-1 for both drugs in spiked human plasma.