Stability Indicating HPTLC Method for Simultaneous Estimation of Sacubitril and Valsartan in their Pharmaceutical Dosage Form

Abstract

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and completely validated for the estimation of Valsartan and Sacubitril in pharmaceutical dosage forms. Quantification of Valsartan and Sacubitril were carried out with precoated silica gel aluminum Plate 60 F254, (20 cm ×10 cm) 100 μm thickness as stationary phase. Toluene: Methanol: Ethyl Acetate: Glacial Acetic acid (8:2:1:1 % v/v/v). The optimized chamber saturation time before chromatographic development was 20 min at room temperature (25ºC ± 2). The length of chromatographic run was 8 cm which took average 15 min to develop. Densitometry scanning was performed using Camag TLC scanner IV with Win CATS software (V 1.4.6.2002, Camag). Optimized chromatogram of Valsartan and Sacubitril having Rf of 0.43 and 0.33, respectively. Linear relationship between peak area and concentration of standard was evaluated over the concentration range expressed in ng/band by making five replicate measurements in the concentrations range of 400-1400 ng/band and 4000-14,000 ng/band, respectively for Valsartan and Sacubitril. Literature reveals that there was no any method developed using HPTLC in simultaneous estimation of Valsartan and Sacubitril in their pharmaceutical dosage form. The proposed method can be successfully applied for the estimation of drug content of different marketed formulations.