Research Article | Volume: 8, Issue: 2, February, 2018

Validated Eco-Friendly Chromatographic Methods for Simultaneous Determination of Sacubitril and Valsartan in Spiked Human Plasma and in Pharmaceutical Formulation

Amal Mahmoud Abou Al Alamein   

Open Access   

Published:  Feb 27, 2018

DOI: 10.7324/JAPS.2018.8202
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 × 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.


Keyword:     Sacubitril Valsartan HPLCHPTLC Green chemistry.


Citation:

Abou Al Alamein AM. Validated Eco-Friendly Chromatographic Methods for Simultaneous Determination of Sacubitril and Valsartan in Spiked Human Plasma and in Pharmaceutical Formulation. J App Pharm Sci, 2018; 8(02): 011-017.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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