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Development and validation of a specific stability indicating high performance liquid chromatographic method for valsartan.

Rao K, Jena N, Rao M - J Young Pharm (2010)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Roland Institute of Pharmaceutical Sciences, Berhampur-760010, Orissa, India.

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.

No MeSH data available.


Chemical structure of valsartan
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Figure 0001: Chemical structure of valsartan

Mentions: Valsartan is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) 1,1’-biphenyl]-4-yl]methyl]-L-valine [Figure 1]. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Its empirical formula is C24H29N5O3, its molecular weight is 435.5. Valsartan is a white fine powder. 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.


Development and validation of a specific stability indicating high performance liquid chromatographic method for valsartan.

Rao K, Jena N, Rao M - J Young Pharm (2010)

Chemical structure of valsartan
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3021695&req=5

Figure 0001: Chemical structure of valsartan
Mentions: Valsartan is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) 1,1’-biphenyl]-4-yl]methyl]-L-valine [Figure 1]. Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Its empirical formula is C24H29N5O3, its molecular weight is 435.5. Valsartan is a white fine powder. 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.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Roland Institute of Pharmaceutical Sciences, Berhampur-760010, Orissa, India.

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.

No MeSH data available.