ABSTRACT:
Valsartan is an orally active antihypertensive agent which belongs to the category of angiotensin II type I receptor antagonists. Valsartan is used for the treatment of heart failure, hypertension, myocardial infraction and diabetic nephropathy. A new stability indicating RP-HPLC was proposed for the quantification of Valsartan by using an ion-pairing agent, tetra butyl ammonium hydrogen sulphate. Mobile phase mixture consisting of 10 mM tetra butyl ammonium hydrogen sulphate and methanol (25: 75, v/v) was selected with a flow rate of 1 ml/min using Agilent C18 column (Detection wavelength 250 nm). The LOD and LOQ were found to be 0.0291 µg/mL and 0.0897 µg/mL respectively. Linearity was observed over the concentration 0.1-50 µg/mL with linear regression equation, y = 36571x + 13532 and the method is precise, accurate and robust. Stress degradation studies were performed and the method was found to be selective and specific.
Cite this article:
NS Yamani, Mukthinuthalapati Mathrusri Annapurna. New stability indicating liquid chromatographic method for the estimation of Valsartan in pharmaceutical dosage forms . Research Journal of Pharmacy and Technology 2023; 16(3):1484-0. doi: 10.52711/0974-360X.2023.00244
Cite(Electronic):
NS Yamani, Mukthinuthalapati Mathrusri Annapurna. New stability indicating liquid chromatographic method for the estimation of Valsartan in pharmaceutical dosage forms . Research Journal of Pharmacy and Technology 2023; 16(3):1484-0. doi: 10.52711/0974-360X.2023.00244 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-3-80
REFERENCES:
1. Criscione L, Gasparo M, Buhlmayer P, Whitebread S, Ramjoue H, Wood J. Pharmacological profile of Valsartan: A potent, orally active, nonpeptide antagonist of the angiotensin II AT1-receptor subtype. Br J Pharmacol. 1993; 110: 761-767.
2. Zhou G, Cheung AK, Liu X, Huang Y: Valsartan slows the progression of diabetic nephropathy in db/db mice via a reduction in podocyte injury, and renal oxidative stress and inflammation. Clin Sci (Lond). 2014; 126(10): 707-720.
3. Chiolero A, Burnier M: Pharmacology of valsartan, an angiotensin II receptor antagonist. Expert Opin Investig Drugs. 1998; 7(11): 1915-1925.
4. Daneshtalab N, Lewanczuk RZ and Jamali F. High performance liquid chromatographic analysis of angiotensin-II receptor antagonist Valsartan using a liquid extraction method. Journal of Chromatogr B AnalytTechnol Biomed Life Science. 2002; 766: 345-359. Macek J, Klima J, Ptacek P. Rapid determination of Valsartan in human plasma by protein precipitation and high-performance liquid chromatography. J Chromatogr B. 2006; 832: 169-172.
5. Afshin Z, Alireza S, Seyed MF, Hooman M. Rapid quantification of Valsartan in human plasma by liquid chromatography using a monolithic column and a fluorescence detection: Application for pharmacokinetic studies. Sci. Pharm. 2008, 76(3), 439-450.
6. Nozomu Koseki, Hiroto Kawashita, Hisanori Hara, Miyuki Niina, Makoto Tanaka, Ryosei Kawai, Yusuke Nagae, Naoki Masuda. Development and validation of a method for quantitative determination of Valsartan in human plasma by liquid chromatography-tandem mass spectrometry, Journal of Pharmaceutical and Biomedical Analysis, 2007, 43(5), 1769-1774.
7. Tatar S and Saglik S. Comparison of UV- and second derivative-spectrophotometric and LC methods for the determination of Valsartan in pharmaceutical formulation. J Pharm Biomed Anal., 2002, 30, 371-375.
8. Rekha P, Shree P, Bhargav Y, Reddy GR (2019) RP-HPLC method development and validation of Valsartan in bulk and its tablet dosage form. J Biomed Pharm Sci 2: 122.
9. Nagakanyaka Devi P, Devala Rao G, Satyanarayana B and Deepthi P. Development and validation of RP-HPLC method for quantification of Valsartan and its pharmaceutical formulations. International Journal of Drug Development and Research, 2013, 5 (3): 199-205.
10. Haque MA, Amrohi SH, Prashanth Kumar K, Nivedita G, Pradeep Kumar T, Dibyalochan Mohanty and Prakash VD. Stability indicating RP-HPLC method for the estimation of Valsartan in pharmaceutical dosage form. IOSR Journal of Pharmacy 2012; 2(4): 12-18.
11. Rao K, Jena N, Rao M. Development and validation of a specific stability indicating high performance liquid chromatographic method for Valsartan. J Young Pharm. 2010; 2(2): 183-189.
12. Lalit Kumar, Sreenivasa Reddy M, Renuka SM and Girish PK. Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharmaceutical Journal, 23, 2015, 549-555.
13. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
14. ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.