Abstract
Objective: This study aims to develop and validate a stability indicating HPLC method for simultaneous estimation of sacubitril and valsartan in pharmaceutical dosage form.Methods: Sacubitril and valsartan separation were achieved by LC-20 AT C18 (250 mm x 4.6 mm) column and buffer (potassium phosphate, pH 3.0): methanol (50:50) as mobile phase, at a flow rate of 1 ml/min (millilitre per minute). Detection was carried out at 224 nm (nanometer). The different HPLC experimental parameters were optimized and the method was validated according to the standard guideline. Forced degradation experiments were carried out by exposing sacubitril and valsartan standard and sample for thermal, photolytic, oxidative and acid-base hydrolytic stress conditions.Results: Retention time of sacubitril and valsartan were found to be 4.170 min (minute) and 6.530 min (minute) respectively. The method has been validated for linearity, accuracy, precision, LOD, and LOQ. Linearity observed for sacubitril is 12.25-36.75 μg/ml (microgram per milliliter) and for valsartan is 12.75-38.25 μg/ml (microgram per milliliter). The results showed that sacubitril and valsartan and the other degradation products were fully resolved and thus the proposed method is stability-indicating.Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of valsartan and sacubitril in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of sacubitril and valsartan tablet.
Highlights
Sacubitril is chemically 4-[[(2S, 4R)-5-ethoxy-4-methyl-5-oxo-1-(4phenyl-phenyl) pentan-2-yl] amino]-4-oxobutanoic acid [1]
A literature search reveals that only two analytical methods were reported for simultaneous estimation of sacubitril and valsartan from rat plasma using LC-MS/MS [16] and from a synthetic mixture using HPLC [17]
There is no stability indicating analytical methods were reported for simultaneous estimation of sacubitril and valsartan
Summary
Sacubitril is chemically 4-[[(2S, 4R)-5-ethoxy-4-methyl-5-oxo-1-(4phenyl-phenyl) pentan-2-yl] amino]-4-oxobutanoic acid [1]. Valsartan is chemically N-(1-oxopentyl)-N-[[2'(1Htetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-Lvaline [4,5,6,7]. Methods such as HPLC [8,9,10], LC-MS [11,12], protein precipitation [13] and simultaneous UV-spectrophotometric methods [14,15] are reported for estimation of valsartan alone or in combination with other agents. There is no stability indicating analytical methods were reported for simultaneous estimation of sacubitril and valsartan. Rapid, sensitive and accurate stability indicating HPLC method was developed for the simultaneous estimation of sacubitril and valsartan from API and pharmaceutical dosage form
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
