• S. Naazneen St Mary’s College of Pharmacy, Secunderabad, Andhra Pradesh, India
  • A. Sridevi IPT, Sri Padmawathi Mahila VishwaVidyalayam, Tirupathi, Andhra Pradesh, India


Degradation study, HPLC method, Sacubitril, Valsartan


Objective: A stability-indicating high performance liquid chromatographic (HPLC) method was developed and validated for the estimation of combined tablet formulation of valsartan and sacubitril.

Methods: Chromatographic separation was optimized by gradient HPLC on a C18 column [Xterra, 250 x 4.6 mm, 5µ] utilizing a mobile phase consisting acetonitrile, methanol and potassium dihydrogen phosphate, pH 3.8 in the ratio of 30: 50:20 v/v at a flow rate of 1 ml/min with UV detection at 263 nm.

Results: The retention time of sacubitril and valsartan was 3.01 min and 4.22 min respectively. Good linearity obtained over the range of 20μg/ml to 160μg/ml for valsartan and sacubitril. The correlation coefficient was found to be 0.999and0.998 for sacubitril and valsartan respectively. The % RSD of precision for sacubitril and valsartan was found to be 0.31 and 0.27 respectively. The % mean recovery was found to be 99.20-99.54% for valsartan and 99.85-100.90% for sacubitril. The results obtained for accuracy, precision, LOD, LOQ and ruggedness were within limits.

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 valsartan and sacubitril tablet.


Download data is not yet available.


Budavari S. The Merck index. 14th ed. Whitehouse Station. NJ Merck and Co. Press; 2006.

Neil MJ, Smith A, Heckelman PE, Kinneary JF. The Merck Index: An Encyclopedia of Chemicals. Edition. 14. Drugs and Biologicals; 2006. p. 1767.

Criscione L, Bradley W, Buhlmayer P, Whitebread S, Glazer R, Lloyd P, Mueller P, et al. Clinical advantage of valsartan. Drug Rev 1995;13:230-50.

Oparil S, Dyke S, Harris F, Kief J, Jamaes D, Hester A, et al. The efficacy and safety of valsartan compared with placebo in the treatment of patients with essential hypertension. Clin Ther 1996;18:797-810.

The United States Pharmacopoeia. 31, National Formulary, 26. Vol. 2 US Pharmacopoeia Convention, INC; Rockville M; 2008. p. 3496-8.

Kocyigit Kaymacoglu B, Unsalan S, Rollas S. Determination and validation of Ketoprofen, Pantoprazole, and Valsartan together in human plasma by high-performance liquid chromatography. Pharmazie 2006;61:586-9.

Daneshtalab N, Lewanczuk RZ, Jamali F. High performance liquid chromatographic analysis of angiotensin-II receptor antagonist Valsartan using a liquid extraction method. J Chromatogr B: Anal Technol Biomed Life Sci 2002;766:345-59.

Gonzalez L, Lopez JA, Alonso RM, Jimenez RM. Fast screening method for the determination of angiotensin II receptor antagonists in human plasma by high-performance liquid chromatography with fluorimetric detection. J Chromatogr A 2002;8:49-60.

Koseki N, Kawashita H, Hara H, Niina M, Tanaka M, Kawai R, et al. Development and validation of a method for quantitative determination of valsartan in human plasma by liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal 2007;43:1769-74.

Li H, Wang Y, Jiang Y, Tang Y, Wang J, Zhao L, et al. A liquid chromatography/tandem mass spectrometry method for the simultaneous quantification of valsartan and hydrochlorothiazide in human plasma. J Chromatogr B: Anal Technol Biomed Life Sci 2007;852:436-42.

Selvan PS, Gowda KV, Mandal U, Solomon WD, Pal TK. Simultaneous determination of fixed dose combination of nebivolol and valsartan in human plasma by liquid chromatographic-tandem mass spectrometry and its application to pharmacokinetic study. J Chromatogr B: Anal Technol Biomed Life Sci 2007;858:143-50.

Macek J, Klima J, Ptacek P. Rapid determination of Valsartan in human plasma by protein precipitation and high-performance liquid chromatography. J Chromatogr B: Anal Technol Biomed Life Sci 2006;832:169-72.

Hillaert S, Bossche VW. Simultaneous determination of Hydrochlorothiazide and several angiotensin-II receptor antagonists by capillary electrophoresis. J Pharm Biomed Anal 2003;31:329-39.

Satana E, Altinay S, Goger NG, Ozkan SA, Sentürk Z. Simultaneous determination of valsartan and hydrochlorothiazide in tablets by first-derivative ultraviolet spectrophotometry and LC. J Pharm Biomed Anal 2001;5:1009-13.

Tatar S, Saglik S. Comparison of UV-and second derivative-spectrophotometric and LC methods for the determination of Valsartan in a pharmaceutical formulation. J Pharm Biomed Anal 2002;30:371-5.

National Center for Biotechnology Information. PubChem Compound Database; CID=9811834. Available from: [Last accessed on 17 Aug 2016]

Voors AA, Dorhout B, Van Der Meer P. The potential role of valsartan+AHU377 (LCZ696) in the treatment of heart failure. Expert Opin Investig Drugs 2013;22:1041-7.

Gu J, Noe A, Chandra P, Al-Fayoumi S, Ligueros-Saylan M, Sarangapani R, et al. Pharmacokinetics and pharmacodynamics of LCZ696, a novel dual-acting angiotensin receptor neprilysin inhibitor (ARNi). J Clin Pharmacol 2010;50:401-14.

Novartis AG. Novartis’ new heart failure medicine LCZ696, now called Entresto, approved by FDA to reduce the risk of cardiovascular death and heat failure hospitalisation. Available from Novartis -new-heart-failure-medicine-lcz696-now-called-entrestotm-approved-fda. [Last accessed on 29 Jul 2015]

Chunduri RHB, Dannana GS. Development and validation of a reliable and rapid LC-MS/MS method for simultaneous quantification of sacubitril and valsartan in rat plasma and its application to a pharmacokinetic study. Biomed Chromatogr 2016;30:1467–75.

Kena H Patel, Shailesh V, Luhar, Sachin B Narkhede. Simultaneous estimation of sacubitril and valsartan in the synthetic mixture by RP-HPLC method. J Pharm Sci Biosci Res 2016;6:262-9.

ICH guidelines for the stability of new drug substances and products. Q1A(R2) ICH, Geneva; 2005. p. 1-13.

ICH guidelines for validation of analytical procedures: text and methodology. Q2(R1) ICH, Geneva; 2005. p. 1-14.

Sindhusri M, Swetha T, Ramadevi A, Ashok Kumar A. A novel rapid rp-hplc method development and validation for the quantitative estimation of balofloxacin in tablets. Int J Pharm Pharm Sci 2014;7:319-22.

Raveendra Babu G, Lakshmana Rao A, Venkateswara Rao J. A rapid RP-HPLC method development and validation for the quantitative estimation ribavirin in tablets. Int J Pharm Pharm Sci 2014;7:60-3.

Srinidhi M, Mushabbar Basha MD, Raj Kumar V, Rajendra Kumar J. Stability indicating RP-HPLC method development and validation for the estimation of sumatriptan in bulk and pharmaceutical dosage form. J Appl Pharm Sci 2016;6:20-5.



How to Cite

Naazneen, S., & Sridevi, A. (2016). DEVELOPMENT OF ASSAY METHOD AND FORCED DEGRADATION STUDY OF VALSARTAN AND SACUBITRIL BY RP-HPLC IN TABLET FORMULATION. International Journal of Applied Pharmaceutics, 9(1), 9–15. Retrieved from



Original Article(s)