Determination of Acetaldehyde Content in Candesartan Cilexetil by HPLC
By: Kumar, S. S
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Contributor(s): Srivastava, R. K.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2018Edition: Vol. 80 (04) July-August.Description: 744-748.Subject(s): PHARMACEUTICS | Impurity | TTC | DNPH | ValidationOnline resources: Click here
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Indian journal of pharmaceutical sciencesSummary: A sensitive, cost-effective, reproducible high-performance liquid chromatography method was developed and validated for quantitative determination of acetaldehyde in candesartan cilexetil using the concept of threshold of toxicological concern. Acetaldehyde is reacted with 2,4-dinitrophenylhydrazine to form a Schiff base product with an absorbing maximum at 364 nm. Effective chromatographic separation was achieved on an Inertsil ODS 3V, 250×4.6 mm, 5 µm column with a mobile phase of 40:60 v/v water and acetonitrile and at a flow rate of 1.0 ml/min. The column temperature was controlled at 25° and the injection volume was 30 µl. These conditions resolved the dinitrophenylhydrazine-acetaldehyde product with unreacted dinitrophenylhydrazine, the drug substances and related impurities, as well as diluent peak within 20 min. The retention time of dinitrophenylhydrazine-acetaldehyde product was approximately 10.6 min. The method was linear, accurate, precise, specific, rapid and found suitable for this analysis.
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School of Pharmacy Archieval Section | Not for loan | 2018305 |
A sensitive, cost-effective, reproducible high-performance liquid chromatography method was developed and validated for quantitative determination of acetaldehyde in candesartan cilexetil using the concept of threshold of toxicological concern. Acetaldehyde is reacted with 2,4-dinitrophenylhydrazine to form a Schiff base product with an absorbing maximum at 364 nm. Effective chromatographic separation was achieved on an Inertsil ODS 3V, 250×4.6 mm, 5 µm column with a mobile phase of 40:60 v/v water and acetonitrile and at a flow rate of 1.0 ml/min. The column temperature was controlled at 25° and the injection volume was 30 µl. These conditions resolved the dinitrophenylhydrazine-acetaldehyde product with unreacted dinitrophenylhydrazine, the drug substances and related impurities, as well as diluent peak within 20 min. The retention time of dinitrophenylhydrazine-acetaldehyde product was approximately 10.6 min. The method was linear, accurate, precise, specific, rapid and found suitable for this analysis.
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