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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.


Typical chromatogram representing the degradation behavior of valsartan in acid hydrolysis
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Figure 0002: Typical chromatogram representing the degradation behavior of valsartan in acid hydrolysis

Mentions: Forced degradation in acidic media was performed by taking an aliquot of stock solution in a 10 ml volumetric flask and diluted up to the mark with HCl (0.75 N, 1.5 N) to obtain a final concentration of 100 mcg/ml. The flask was kept aside at room temperature for 2 h and neutralized. Appropriate aliquot was taken from the above solution and diluted with mobile phase to obtain a final concentration of 10 mcg/ml. Similarly, forced degradation in alkaline media was performed using 1.5 N NaOH. The representative chromatograms for acid and alkaline degradation studies are shown in Figures 2 and 3, respectively.


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)

Typical chromatogram representing the degradation behavior of valsartan in acid hydrolysis
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0002: Typical chromatogram representing the degradation behavior of valsartan in acid hydrolysis
Mentions: Forced degradation in acidic media was performed by taking an aliquot of stock solution in a 10 ml volumetric flask and diluted up to the mark with HCl (0.75 N, 1.5 N) to obtain a final concentration of 100 mcg/ml. The flask was kept aside at room temperature for 2 h and neutralized. Appropriate aliquot was taken from the above solution and diluted with mobile phase to obtain a final concentration of 10 mcg/ml. Similarly, forced degradation in alkaline media was performed using 1.5 N NaOH. The representative chromatograms for acid and alkaline degradation studies are shown in Figures 2 and 3, respectively.

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.