Volume : 12, Issue : 10, October – 2025
Title:
METHOD DEVELOPMENT AND VALIDATION OF VALSARTAN BY RP-HPLC
Authors :
M.D. Kaviyarasu, Dr.P.D. Gokulan*, Dr. K.L. Senthilkumar
Abstract :
A simple, precise, accurate, and environmentally friendly RP-HPLC method was developed and validated for the determination of Valsartan in bulk and pharmaceutical formulations. Chromatographic separation was achieved using an Inertsil ODS C8 (100 × 4.6 mm, 5 µm) column with a mobile phase consisting of acetonitrile and potassium dihydrogen phosphate buffer (pH 6.1) in a 30:70 v/v ratio. The flow rate was maintained at 1.5 mL/min, detection was carried out at 247 nm, and the column temperature was kept at 27 °C. The retention time of Valsartan was found to be 4.705 min. The method showed excellent linearity (25–125 µg/mL) with a correlation coefficient of 0.9999, precision with %RSD below 0.5%, and recovery of 99.69%. The LOD and LOQ values were 1.468 µg/mL and 4.45 µg/mL, respectively. The method was validated as per ICH guidelines and successfully applied to commercial tablet dosage forms, proving its suitability for routine quality control analysis.
KEY WORDS: Method development, RP-HPLC, Valsartan, Method validation.
Cite This Article:
Please cite this article in press P.D. Gokulan et al., Method Development And Validation Of Valsartan By Rp-Hplc, Indo Am. J. P. Sci, 2025; 12(10).
REFERENCES:
https://pubchem.ncbi.nlm.nih.gov/compound/Sacubitril
2. https://pubchem.ncbi.nlm.nih.gov/compound/Valsartan
3. Saleh T, Yaser B, Véronique G. Separation and Quantification of Sacubitril-Valsartan Combination in Tablets by a New Ion-pair HPLC. Research J. Pharm. and Tech. 2019; 12(3) :1017-1022.
4. Singh S, Topagi K, Damle M. A Validated RP-HPLC Method for Simultaneous Determination of Ramipril and Valsartan in Pharmaceutical Formulation. Research J. Pharm. and Tech. 2009; 2 (4): 749-752.
5. Chitlange S et al. A stability-indicating reverse phase high performance liquid chromatography method for the simultaneous determination of ramipril and valsartan in pharmaceutical dosage form. Research J. Pharm. and Tech. 2008; 1(3):215-217.
6. Choudhari G et al. Simultaneous Spectrophotometric Estimation of Valsartan and Hydrochlorothiazide in Tablet Formulations. Research J. Pharm. and Tech. 2009; 2 (4):723-726.
7. Singh S, Topagi K, Damle M. A Validated High Performance Thin Layer Chromatographic Method for Simultaneous Estimation of Nebivolol Hydrochloride and Valsartan in Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2009; 2 (4): 746-748.
8. Murugan S, Vetrichelvan T. Absorbance Ratio and First Order Derivative Spectroscopic Methods for Simultaneous Determination of Sacubitril and Valsartan in Bulk and Tablet Dosage Form. Research J. Pharm. and Tech. 2019; 12(11): 5251-5254.
9. Shinde S et al. Quantitation of Valsartan in Human Plasma by High Performance Liquid Chromatography with Fluorescence Detection and its Application to Bioequivalence Study. Research J. Pharm. and Tech. 2009; 2 (3): 487-490.
10. Kumar P et al. Formulation and Evaluation of Valsartan Fast Dissolving Tablets. Research J. Pharm. and Tech. 2011; 4(3):454-456.
11. Thomas J et al. Design and Characterization of Valsartan Co-Crystals to Improve its Aqueous Solubility and Dissolution Behavior. Research J. Pharm. and Tech. 2017; 10(1):26-30.
12. Kumar V et al. Formulation and In Vitro Characterization of Valsartan Solid Dispersions. Research J. Pharm. and Tech. 2009; 2 (3): 502-506.
13. Nayak U et al. Formulation and Evaluation of Multiparticulate Drug Delivery System of Valsartan. Research J. Pharm. and Tech. 2013; 6(1): 96-104.
14. Patel C, Mishra S, Patel M. 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.




