Highly sensitive HPLC method for assay of aliskiren in human plasma through derivatization with 1-naphthyl isocyanate using UV detection

•A simple and sensitive HPLC method has been developed to determine aliskiren (ALI) in human plasma.•ALI response was measured by direct UV detection with high reproducibility, specificity and accuracy.•The proposed method was applied without any interference from endogenous compounds and with good...

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Bibliographic Details
Published in:Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2013-08, Vol.933, p.24-29
Main Authors: Belal, F., Walash, M., El-Enany, N., Zayed, S.
Format: Article
Language:English
Subjects:
Acetonitrile
Aliskiren
Amides - blood
Antihypertensive Agents - blood
Assaying
Chromatography, High Pressure Liquid - methods
Drug Monitoring
Fumarates - blood
HPLC
Human
Humans
Isocyanates
Isocyanates - chemistry
Limit of Detection
Monitoring
Naphthalenes - chemistry
Naphthyl isocyanate derivatization
Phosphoric acid
Plasma
Spectrophotometry, Ultraviolet - methods
Standard deviation
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Summary:•A simple and sensitive HPLC method has been developed to determine aliskiren (ALI) in human plasma.•ALI response was measured by direct UV detection with high reproducibility, specificity and accuracy.•The proposed method was applied without any interference from endogenous compounds and with good recovery.•The method is suitable for routine therapeutic drug monitoring and for pharmacokinetic studies. A simple and sensitive HPLC method has been developed for the determination of aliskiren in human plasma through derivatization with 1-naphthyl isocyanate. The separation was achieved on a C18 column using a mobile phase consisting of acetonitrile/water/phosphoric acid (45:55:0.01, v/v/v, pH 3.2) in a flow rate of 1mL/min with UV detection at 230nm. Caffeine was used as an internal standard. The factors influencing the derivatization reaction yields were carefully studied and optimized. The method was linear over the concentration range of 5–400ng/mL with a detection limit of 0.5ng/mL and a limit of quantification of 1.0ng/mL. The relative standard deviation was less than 4.2% for both intra-day assay and inter-day assay results. No interferences from endogenous compounds were encountered. The percentage recovery was in the range 97.1–98.6%. The method is suitable for routine therapeutic drug monitoring and for pharmacokinetic studies
ISSN:1570-0232
1873-376X
DOI:10.1016/j.jchromb.2013.06.004