Development and Validation of Stability Indicating Chromatographic Method for Simultaneous Estimation of Sacubitril and Valsartan in Pharmaceutical Dosage Form

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.

Ecological assessment and development of analytical methods for concurrent quantification of valsartan and sacubitril: whiteness comparative study based on relative scoring

“…As a consequence, they are more eco-friendly than the reported chromatographic ones. [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]28 Finally, the proposed methods showed more sensitive calibration ranges than most reported methods. Only one reported HPLC-Flu method 10 has a linearity scale at slightly lower concentrations.…”

“…In addition, LCZ696 was assayed by HPLC using many approaches. 9,10,[12][13][14][15][16][17][18][19][20][21][22][23][24] In addition, VAS and SAB were simultaneously analyzed via spectrouorometric technique. [25][26][27] Very recently, a MEKC method was developed for the same purpose.…”

Development and Validation of Stability Indicating Rp-Uplc Method for the Quantification of Baloxavir Marboxil in Tablet Formulation

“…The developed method for BLMX was subjected for validation for the parameters like system suitability, linearity, robustness, limit of detection (LOD), limit of quantification (LOQ), precision and accuracy as per the guidelines of ICH [5][6][7][8][9].…”

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

“…It is interesting to observe HPLC had been continuously used in development of stability indicating studies of sacubitril and valsartan ( Ahmed et al., 2017 ; Patel et al., 2017 ; Mishara et al., 2017 ; Naazneen and Sridevi, 2017 ; Jyothi and Umadevi, 2018 ; Moussa et al., 2018 ). Various combinations of mobile phases were used to achieve better separation for sacubitril, valsartan and their impurities.…”