LAUSR

A new stability indicating reverse phase HPLC method has been developed, optimized and validated as per International Conference on Harmonization guidelines for the determination of stereoisomers namely (2R)-valsartan, (2S,4S)-sacubitril, (2R,4S)-sacubitril and (2R,4R)-sacubitril in sacubitril-valsartan premix. Primarily, stability indicating separation study was done on reverse phase LC conditions; it was described by peak homogeneity of sacubitril-valsartan and its stereoisomers. Separation achieved on cellulose tris(4-methylbenzoate) packing column Chiralcel OJ-RH(150 mm x 4.6 mm), 5 μm than those of amylose based stationary phase's. Resolution between two arbitrary adjacent analyte was found to be more than 2.0 with 0.1% trifluoroacetic acid in water as mobile phase-A and mobile phase-B consisting of acetonitrile, methanol and trifluoroacetic acid (90:10:0.1 v/v/v). Gradient elution was performed at a flow rate of 1.0 mL/min, column temperature 20°C, injection volume 10 μL, UV detection at 254 nm and run time was 52 mins. The detector response found to be linear (R2  ≥ 0.9998), limit of detection (0.290 μg/mL, 0.122 μg/mL, 0.123 μg/mL and 0.124 μg/mL) and limit of quantification (0.878 μg/mL, 0.370 μg/mL, 0.373 μg/mL and 0.375 μg/mL), respectively. Percentage recovery found to be 98-105. Finally, the proposed method is user-friendly and can be used in bulk drugs analysis. This article is protected by copyright. All rights reserved.