Validated liquid chromatographic determination of a novel ACE inhibitor in the presence of its hydrolytic and oxidative degradation products as per ICH guidelines

Talanta ◽  
2014 ◽  
Vol 119 ◽  
pp. 170-177 ◽  
Author(s):  
Maha A. Hegazy ◽  
Maya S. Eissa ◽  
Osama I. Abd El-Sattar ◽  
Mohamed M. Abd El-Kawy
Keyword(s):  
Ace Inhibitor ◽  
Degradation Products ◽  
Oxidative Degradation ◽  
Chromatographic Determination ◽  
Ich Guidelines ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic

Reverse Phase Liquid Chromatographic Determination of Bisacodyl in Dosage Forms

1985 ◽  
Vol 68 (3) ◽  
pp. 529-532
Author(s):  
Leonard P Valenti ◽  
Cesar A Lau-Cam
Keyword(s):  
Degradation Products ◽  
Chromatographic Determination ◽  
Content Uniformity ◽  
Liquid Chromatograph ◽  
Ultraviolet Detector ◽  
Liquid Chromatographic Determination ◽  
Phase Liquid ◽  
Enteric Coated ◽  
Liquid Chromatographic

Abstract A method is described for the determination of bisacodyl in entericcoated tablets and suppositories by liquid chromatography (LC). The method will also determine the hydrolysis degradation products monoacetylbisacodyl and desacetylbisacodyl. The sample is dissolved in 2- propanol, and the extract is diluted with the mobile phase and injected into a liquid chromatograph fitted with a μBondapak C18 column and an ultraviolet detector set at 254 nm. The column is eluted with methanol- acetonitrile-0.01M citric acid (25 + 25 + 50). The pooled mean recovery value for bisacodyl from commercial enteric-coated tablets and suppositories was 99.7 % with a pooled coefficient of variation (CV) of 0.72%. For content uniformity assays, the CVs were 0.7 and 1.0% for groups of 10 individual commercial suppositories and tablets, respectively. Differences between assay values by the LC and USP XX methods were 0.2% of declared for enteric-coated tablets (n = 5) and 1.0% of declared for suppositories (n = 2). The LC method can determine as little as 0.015 μg of the monoacetyl or desacetyl degradation product.

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