Author(s): Rajeswari Aleti, K. V. Ramana Murthy

Email(s): razi.pharma.87@gmail.com

DOI: 10.52711/0974-360X.2022.00881   

Address: Rajeswari Aleti*, K. V. Ramana Murthy
Department of Pharmaceutics, A.U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam - 530003, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 11,     Year - 2022


ABSTRACT:
Sacubitril and valsartan combination is a member of a new class of agents called angiotensin receptor-neprilysin inhibitors (ARNI’s) which combine neprilysin inhibitor and angiotensin receptor blocker (ARB). It is currently indicated for treating patients with heart failure with reduced ejection fraction (HFrEF) in place of an angiotensin-converting enzyme (ACE) inhibitor or ARB alone. The aim of present investigation is to develop a simple UV spectrophotometric method for the determination of sacubitril and valsartan combination in its pure form and pharmaceutical tablet formulations in 0.1N HCl (pH 1.2) and pH 6.8 phosphate buffer, and further to validate the developed method. The combination in bulk was estimated at ?max of 253 nm in 0.1N HCl and pH 6.8 phosphate buffer. The observed ?max was close to the calculated ?max predicted using Woodward Fieser rules. The method was validated using analytical parameters like linearity, precision, and accuracy as per guidelines laid down by International Conference on Harmonization (ICH). Beer’s law was obeyed in the concentration range of 1–20 µg/mL in both media with correlation coefficient value of 0.999. The accuracy was found between 99-101% in both media. The method showed good reproducibility with % RSD values less than 2. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.5353 µg/mL, 1.6222 µg/mL in 0.1N HCl and 0.395 µg/mL, 1.198 µg/mL in pH 6.8 phosphate buffer respectively indicating its sensitivity. Molar absorptivity of the drug was found to be 3.84x104, 3.68x104 L mole-1 cm-1 and Sandell’s sensitivity values were found to be 0.0249 and 0.025 µg cm-1/0.001 absorbance unit in 0.1 N HCl and pH 6.8 phosphate buffer respectively. The assay values of the drugs in pharmaceutical dosage forms were also found close to the labelled claim. The results demonstrated that the procedure is accurate, precise, and reproducible besides being simple, economical, and less time consuming and hence, suitably applied for routine analysis of sacubitril and valsartan combination in bulk, marketed tablet dosage forms and in vitro dissolution samples.


Cite this article:
Rajeswari Aleti, K. V. Ramana Murthy. Development and validation of UV spectroscopic method for estimation of sacubitril and valsartan combination (LCZ696) in bulk and pharmaceutical tablet dosage forms. Research Journal of Pharmacy and Technology. 2022; 15(11):5232-8. doi: 10.52711/0974-360X.2022.00881

Cite(Electronic):
Rajeswari Aleti, K. V. Ramana Murthy. Development and validation of UV spectroscopic method for estimation of sacubitril and valsartan combination (LCZ696) in bulk and pharmaceutical tablet dosage forms. Research Journal of Pharmacy and Technology. 2022; 15(11):5232-8. doi: 10.52711/0974-360X.2022.00881   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-11-66


REFERENCES:
1.    Ansara AJ, Kolanczyk DM, Koehler JM. Neprilysin inhibition with sacubitril/valsartan in the treatment of heart failure: mortality bang for your buck. Journal of Clinical Pharmacy and Therapeutics. 2016 Apr; 41(2):119-27. doi: 10.1111/jcpt.12363
2.    Edoardo Gronda, Vanoli Emilio, Iacoviello Massimo. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. European Heart Journal Supplements. 2020 Nov 18; 22(Supplement L): L77-L81. doi: 10.1093/eurheartj/suaa140
3.    Polito MV et al. Clinical and echocardiographic benefit of Sacubitril/Valsartan in a real-world population with HF with reduced ejection fraction. Scientific Reports. 2020; 10(1):6665.  doi: 10.1038/s41598-020-63801-2
4.    Ponikowski P et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology. European Journal of Heart Failure. 2016 Aug; 18(8):891-975. doi: 10.1002/ejhf.592
5.    European Medicines Agency assessment report accessed on 24 September 2015. EMA/671279/2015 Committee for Medicinal Products for Human Use (CHMP). Available on www.ema.europa.eu/en/documents/assessment-report/entresto-epar-public-assessment-report_en.pdf
6.    McMurray JJ et al. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF). European Journal of Heart Failure. 2013 Sep;15(9):1062-73. doi: 10.1093/eurjhf/hft052
7.    Minguet J et al. LCZ696: A new paradigm for the treatment of heart failure? Expert Opin. Pharmacother. 2015;16(3):435-46. doi:10.1517/14656566.2015.1000300
8.    Naazneen S, Sridevi A. Development of assay method and forced degradation study of valsartan and sacubitril by RP-HPLC in tablet formulation. International Journal of Applied Pharmaceutics. 2017;9(1):9–15. doi:10.22159/ijap.2017v9i1.15448.
9.    Moussa B et al. Experimental Design Approach in HPLC Method Development: Application for the Simultaneous Determination of Sacubitril and Valsartan in Presence of Their Impurities and Investigation of Degradation Kinetics. Chromatographia. 2018; 81:139–56. doi:10.1007/s10337-017-3425-9
10.    Phalguna Y, Noor Jahan, Indraja N, Satheesh Kumar G. Analytical method development and validation for the estimation of sacubitril and valsartan in combined pharmaceutical dosage forms by RP-HPLC. Asian Journal of Research in Pharmaceutical sciences. 2018; 8(1):09-16. doi: 10.5958/2231-5659.2018.00003.6
11.    Sridevi Ranjitha Karanam, V. Reena Jyothi Swarupa. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2016;6(1):7-14. doi: 10.5958/2231-5675.2016.00002.8.
12.    Saleh Trefi, Yaser Bitar, Veronique Gilard. Separation and Quantification of Sacubitril-Valsartan Combination in Tablets by a New Ion-pair HPLC. Research Journal of Pharmacy and Technology. 2019; 12(3): 1017-22. doi: 10.5958/0974-360X.2019.00168.9
13.    Chunduri RH, 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. Biomedical Chromatography.2016 Sep; 30(9):1467-75. doi: 10.1002/bmc.3707
14.    Ragab MAA, Galal SM, Korany MA, Ahmed AR. First derivative emission spectrofluorimetric method for the determination of LCZ696, a newly approved FDA supramolecular complex of valsartan and sacubitril in tablets. Luminescence. 2017 Dec;32(8):1417-25. doi: 10.1002/bio.3339
15.    Eissa MS, Abou Al Alamein AM. Innovative spectrophotometric methods for simultaneous estimation of the novel two-drug combination: Sacubitril/Valsartan through two manipulation approaches and a comparative statistical study. Spectrochim Acta A Mol Biomol Spectrosc. 2018 Mar 15; 193:365-74. doi: 10.1016/j.saa.2017.12.050
16.    Murugan S and Vetrichelvan T. Absorbance Ratio and First Order Derivative Spectroscopic Methods for Simultaneous Determination of Sacubitril and Valsartan in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2019; 12(11):5251-4. doi: 10.5958/0974-360X.2019.00908.9
17.    Thasneem Banu, Hemant T Kumar, Varaprasad K Rao, Srinivas Y Rao. Application of Simultaneous Equation method for estimation of Sacubitril and Valsartan in Combined Dosage Form. Asian Journal of Research in Chemistry. 2021; 14(2):111-4. doi: 10.5958/0974-4150.2021.00020.1   
18.    International Conference on Harmonization (ICH) Validation of Analytical Procedures: Text and methodology - Q2 (R1), 2005. Available on: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
19.    R.D. Rahane, Punit R. Rachh. Development and Validation of Simultaneous Estimation of Metformin Hydrochloride and Glimepiride in Physiological media. Research Journal of Pharmacy and Technology. 2020; 13(11):5360-4. doi: 10.5958/0974-360X.2020.00937.3
20.    Amit Kumar J. Vyas et al. A Stress Degradation Kinetic Study of Tadalafil Bulk and Tablet Dosage Form by UV Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2020; 10(4):177-81. doi: 10.5958/2231-5675.2020.00032.0
21.    Validation of analytical procedures: text and methodology q2(r1) by ICHHT Guideline. Available on https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
22.    Mohd. Idris et al. Simultaneous Determination of Saccharin and Aspartame in Drinks by UV- Spectrophotometry. Asian Journal of Research in Chemistry. 2011 May;4(5):737-40.
23.    Kalyani Farkade, Mukund Tawar. Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teneligliptin Hydrobromide by UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):195-8.
24.    Denny, R.C. Dictionary of Spectroscopy. Wiley, Newyork.1982; 2nd ed: pp.119-20.
25.    Gurav Suhas B et al. Spectrophotometric Method for Estimation of Efavirenz from Tablet Formulation. Asian Journal of Research in Chemistry. 2011 May;4(5):754-6.
26.    Dissolution methods by USFDA. Available on https://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_getalldata.cfm
27.    Sharma. Y. R. Elementary Organic Spectroscopy: Principles and Chemical Applications. S.Chand Publishing. 2006; 1st ed: pp. 31-49.

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