Author(s):
Priyanka Yadav, Hiral Panchal
Email(s):
ypriyanka09@gmail.com
DOI:
10.52711/0974-360X.2022.00607 
Address:
Priyanka Yadav1, Hiral Panchal2
1PhD Research Scholar, Gujarat Technological University, Ahmedabad, Gujarat, India.
2Professor and HOD, Department of Pharmaceutical Quality Assurance, Shree Swaminarayan Sanskar Pharmacy College, Zundal, Gujarat, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 8,
Year - 2022
ABSTRACT:
Sacubitril/Valsartan (SAC/VAL) is a combination drug used for the treatment of heart failure. In the present work, rapid, sensitive, specific, and robust high-performance liquid chromatography method was developed and validated for the simultaneous estimation of SAC/VAL in pharmaceutical dosage form. The chromatographic separation was achieved on Zorbax SB C8, (150 × 4.6 mm, 5 µm) column. The peaks were eluted using 0.02 M ammonium acetate buffer: acetonitrile (55:45, %v/v) (pH-3.0 adjusted with glacial acetic acid) as mobile phase. The flow rate was set at 1.0 ml/minute and the analytes were monitored in the range of 200–400 nm using a Photo Diode Array (PDA) detector for 10 minutes run time. The method was validated as per ICH Q2 (R1) guideline and all the validation parameters were found within the acceptance criteria. The forced degradation study for SAC/VAL showed that the drugs were prone to acidic, alkaline, oxidative stress conditions. All the degradation products were separated from each other, SAC/VAL and their degradation products showing the stability indicating criteria of the method. The developed method can be used for estimation of assay from bulk or their finished products with good efficiency.
Cite this article:
Priyanka Yadav, Hiral Panchal. Stability indicating RP-HPLC Method for Simultaneous estimation of Valsartan and Sacubitril in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(8):3627-3. doi: 10.52711/0974-360X.2022.00607
Cite(Electronic):
Priyanka Yadav, Hiral Panchal. Stability indicating RP-HPLC Method for Simultaneous estimation of Valsartan and Sacubitril in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(8):3627-3. doi: 10.52711/0974-360X.2022.00607 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-8-49
REFERENCES:
1. Rang HP. Dale MM. Ritter JM. Flower RJ. Rang and Dale‘s Pharmacology. Churchill Livingstone. Elsevier Science Ltd. New York. 2007; 6th Edition: 298-320.
2. Brunton LL. Lazo JS. Parker KL. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. The MC Graw Hill companies Inc. New York. 2001; 11th Edition: 833-846.
3. Harvey RA. Champe PC. Lippincott’s Illustrated Reviews. Pharmacology. Lippincott Williams and Wilkins Publications. 2003; 4th Edition: 320.
4. ICH Harmonized Tripartite Guideline. Impurities in new drug substances Q3A (R2). International conference on Harmonization. IFPMA. Geneva. Switzerland. 2003: 1-11.
5. ICH Harmonized Tripartite Guideline. Stability testing of new drug substances and Products Q1A (R2). International conference on Harmonization. IFPMA. Geneva. Switzerland. 2003: 1-15.
6. O'Neil MJ. The Merck Index-An Encyclopaedia of Chemicals Drugs and Biological. Royal Society of Chemistry. Cambridge. UK. 2013; 15th Edition: 1840.
7. Valsartan. Drug profile. June 2005. http://www.drugbank.ca/drugs/DB00177.
8. Sacubitril. Drug profile. October 2015. http://www.drugbank.ca/drugs/DB09292.
9. Sacubitril. Drug profile. National Library of medicine. https://pubchem.ncbi.nlm.nih.gov/compound/Sacubitril.
10. Indian pharmacopoeia. Indian Pharmacopoeia Commission. Government of India ministry of health and family welfare. Controller of India. Delhi. 2010: 1580.
11. The United States pharmacopoeia 32 National Formulary 27. Asian Edition. The United States Pharmacopoeia Convention. Rockville. 2009: 3842.
12. Chandana O S S. Ravichandra Babu R. Method Development and Validation of Valsartan and Its Impurities by High Performance Liquid Chromatography. Asian Journal of Pharmaceutical Analysis 2017; 7(2):87-92. doi.org/10.5958/2231-5675.2017.00015.1
13. Dr. Chandana O S S. Assay Method Development and Validation for Valsartan using high Performance liquid Chromatography. Asian Journal of Pharmaceutical Analysis 2020; 10(2):103-108. doi.org/10.5958/2231-5675.2020.00018.6
14. Hamid Khan. Identification and Characterization of Degradation Products of Valsartan by UPLC/Q-TOF-MS Technique. Asian Journal of Pharmaceutical Research 2021; 11(1):1-5. doi.org/10.5958/2231-5691.2021.00001.0
15. Chitlange SS. Stability Indicating RP- HPLC Method for Simultaneous Estimation of Valsartan and Amlodipine in Capsule Formulation. Asian Journal of Research in Chemistry 2008 Sep; 1(1):15-18.
16. Yogeshwar Reddy M. Low-Level Determination of Residual 4-Bromo Methyl-2'-Cyanobiphenyl in Valsartan by Liquid Chromatography-Mass Spectrometry. Asian Journal of Research in Chemistry 2010; 3(2):407-410.
17. Gawai Mamata N. New UV – Spectrophotometric Method Development and Validation of Valsartan in Bulk and Pharmaceutical Dosage Forms. Asian Journal of Research in Chemitry 2016; 9(9):441-444. doi.org/10.5958/0974-4150.2016.00066.3
18. Leela Madhuri P. UV Spectrophotometric Method for Estimation of Sacubitril in Synthetic Mixture. Asian Journal of Research in Chemistry 2019; 12(1):07-10. doi.org/10.5958/0974-4150.2019.00002.6
19. Sandhya Raj S. Preparation and Characterization of Valsartan Loaded Alginate Mucoadhesive Microcapsules. Research Journal of Pharmaceutical Dosage Forms and Technology 2011; 3(1):07-11.
20. SR Shinde. Quantitation of Valsartan in Human Plasma by High Performance Liquid Chromatography with Fluorescence Detection and its Application to Bioequivalence Study. Research Journal of Pharmacy and Techology 2009; 2 (3):487-490.
21. Jino Elsa Thomas. Design and Characterization of Valsartan Co-Crystals to Improve its Aqueous Solubility and Dissolution Behavior. Research Journal of Pharmacy and Technology 2017; 10(1):26-30. doi.org/10.5958/0974-360X.2017.00007.5
22. Haque MA. Amrohi SH. Stability indicating RP-HPLC method for the estimation of valsartan in pharmaceutical dosage form. Journal of Pharmacy and Biological sciences 2012; 2(4):12-18.
23. Kharoaf M. Malkieh N. Tablet formulation and development of a validated stability indicating HPLC method for quantification of valsartan and hydrochlorthiazide combination. International Journal of Pharmacy and Pharmaceutical Sciences 2012; 4(3):284-90.
24. Mustafa C. Mustafa SK. HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies. Brazilian Journal of Pharmaceutical Sciences 2010; 46(4):761-768.
25. Samya M. Development and validation of HPLC method for simultaneous determination of amlodipine, valsartan, hydrochlorothiazide in dosage form and spiked human plasma. American Journal of Analytical Chemistry 2012; 3(1):422-430. doi.org/10.4236/ajac.2012.36055
26. Naga RT. Ravi KD. Assay of valsartan and sacubitril in combined dosage form by RP-HPLC. Journal of Applicable Chemistry 2017; 6(5):1004-1011.
27. Swathi V. Parthiban P. New method development and validation for the simultaneous estimation of sacubitril and valsartan in bulk and pharmaceutical dosage forms. International Journal of Research 2017; 4(1):17-24.
28. Vegesna S. RP-HPLC method development and validation for the simultaneous estimation of sacubitril and valsartan in bulk and pharmaceutical dosage form. World Journal of Pharmaceutical and Life Sciences 2017; 3(9):185-191.
29. Kena HP. Shailesh V. Simultaneous estimation of sacubitril and valsartan in synthetic mixture by RP-HPLC method. Journal of Pharmaceutical Science and Bioscientific Research 2016; 6(3):262-269.
30. Madana GN. Sridhar C. RP-UPLC method for simultaneous estimation of sacubitril and valsartan in its bulk and tablet dosage form with force degadation studies. International Journal of ChemTech Research 2017; 10(4):279-287.
31. Muqhtar A. Stability indicating RP-HPLC method for simultaneous estimation of sacubitril and valsartan in bulk and combined pharmaceutical dosage form. World Journal of Pharmacy and Pharmaceutical Sciences 2017; 6(4):1714-1728. doi.org/10.20959/wjpps20174-8965
32. Patel CJ. Simultaneous estimation of sacubitril and valsartan in pharmaceutical dosage form by development and validation of stability indicating chromatographic method. World Journal of Pharmacy and Pharmaceutical Sciences 2017; 6(7):1434-1448.
33. Farheen B. Stability indicating analytical method development and validation for estimation of sacubitril and valsartan in bulk and pharmaceutical dosage form using RP-HPLC. International Journal of Farmacia 2016; 2(1):79-87.