Abstract
A stability-indicating HPLC assay method has been developed and validated for valsartan in bulk drug and pharmaceutical dosage forms. An isocratic RP-HPLC was achieved on Waters 2695 using Symmetry C18 (250mm × 4.6mm × 5μ) column with the mobile phase consisting of 0.02 mM sodium dihydrogen ortho-phosphate, pH adjusted to 2.5 using ortho-phosphoric acid (solvent A), and acetonitrile (solvent B) in the ratio of 58:42 %v/v. The stress testing of valsartan was carried out under acidic, alkaline, oxidative, thermal, and photolytic conditions. Valsartan was well resolved from its degradation products. The proposed method was validated as per ICH guidelines. The method was found to be suitable for the quality control of valsartan in bulk and pharmaceutical dosage forms as well as the stability-indicating studies.
Highlights
Valsartan is chemically described as N-(1-oxopentyl)N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-Lvaline [Figure 1]
The chromatographic column used was Waters Symmetry C18 250 × 4.6 mm × 5 μm and it was maintained at ambient temperature for the separation and the method validated for the determination of valsartan tablets
Intentional degradation was attempted to under different stress conditions to evaluate the ability of the proposed method to separate valsartan from its degradation products
Summary
Valsartan is chemically described as N-(1-oxopentyl)N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-Lvaline [Figure 1]. Orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Its empirical formula is C24H29N5O3, its molecular weight is 435.5. It is soluble in ethanol and methanol and slightly soluble in water. It is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg, or 320 mg of valsartan
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
