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Application of TLC-Densitometric Method for Simultaneous Determination of Sacubitril and Valsartan in their Newly Approved Pharmaceutical Formulation


Khalid A.M. Attia, Mohammed W.I. Nassar, Ahmed El-Olemy, Sherif Ramzy*

Article (PDF)

Keywords

Entresto (sacubitril/valsartan), Thin layer chromatography, Densitometry.

Abstract

Entresto ® (Sacubitril/valsartan) is a recently approved oral drug for the treatment of symptomatic chronic heart failure. In this study, simple, rapid and economic TLC-densitometric method has been developed for simultaneous determination of sacubitril and valsartan in their mixture. The TLC-densitometric separation process has beenachieved on pre-coated silica gel (60 GF254) plates using toluene–ethylacetate– methanol mixture(4:4:2, by volume) as a developing system. The well separated bands have been quantified densitometricallyat 260nm. Calibration graphs were found to be linear over a concentration range of 0.1–0.6μgband -1 for two drugs. The proposed method has been successfully applied to the analysis of sacubitril and valsartan in Entresto ® tablets.