Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 53; no. 3; pp. 483 - 489
• Main Authors: Krishnaiah, Ch, Reddy, A. Raghupathi, Kumar, Ramesh, Mukkanti, K.
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 02.11.2010; Elsevier
• Subjects: Analysis; Analytical, structural and metabolic biochemistry; Angiotensin II Type 1 Receptor Blockers - analysis; Angiotensin II Type 1 Receptor Blockers - chemistry; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Dosage Forms; Drug Stability; Forced degradation; Fundamental and applied biological sciences. Psychology; General pharmacology; Limit of Detection; Medical sciences; Pharmacology. Drug treatments; Stability-indicating; Tetrazoles - analysis; Tetrazoles - chemistry; UPLC; Validation; Valine - analogs & derivatives; Valine - analysis; Valine - chemistry; Valsartan; Validation; Stability-indicating; Valsartan; UPLC; Forced degradation; Ultra performance liquid chromatography; Imidazole derivatives; Tetrazole derivatives; Peptides; Chemical stability; Peptide hormone; Determination; Octapeptide; Angiotensin II; Valine derivatives; Quantitative analysis; Renin angiotensin system; Biphenyl derivatives; Storage stability; Aminoacid; Quality control; Dosage form; Antihypertensive agent; Active ingredient; Sartan derivatives; Angiotensin antagonist; Degradation product
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2010.05.022

A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative determination of purity of Valsartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. The method was developed using Waters Aquity BEH C18 (100 mm × 2.1 mm, 1.7 μm) column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 225 nm, the run time was within 9.5 min, which Valsartan and its seven impurities were well separated. Valsartan was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Valsartan was found to degrade significantly in acid and oxidative stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of Valsartan in pharmaceutical dosage forms.