scholarly journals Development and Validation of a High-Performance Liquid Chromatographic Method for the Determination of Cinitapride in Human Plasma

2018 ◽  
Vol 2018 ◽  
pp. 1-5
Author(s):  
Boovizhikannan Thangabalan ◽  
Getu Kahsay ◽  
Tadele Eticha
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Liquid Chromatographic Method ◽  
Us Fda ◽  
Development And Validation ◽  
Liquid Chromatographic

A precise and reliable reversed-phase high-performance liquid chromatographic method with ultraviolet detection was developed and validated to determine cinitapride in human plasma. After liquid-liquid extraction, chromatographic separation was achieved on a Nucleosil C18 (25 cm × 4.6 mm, 5 µm) column with an isocratic elution consisting of 10 mM ammonium acetate (pH 5.2), methanol, and acetonitrile, 40 : 50 : 10, v/v/v. The developed method was validated as per US FDA guidelines for its linearity, selectivity, sensitivity, precision, accuracy, and stability. Satisfactory findings were obtained from the validation studies. The linearity range of the method was 1 to 35 ng/mL while the extraction recovery of cinitapride in human plasma was more than 86%. The percent coefficient of variation of both intraday and interday precision was ≤7.1%.

scholarly journals A Reversed-Phase High-Performance Liquid Chromatographic Method for the Determination of Zafirlukast in Pharmaceutical Formulations and Human Plasma

2006 ◽  
Vol 89 (6) ◽  
pp. 1557-1564 ◽  
Author(s):  
İncilay SÜsÜl ◽  
Sacide AltinÖz
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Chromatographic Method ◽  
Pharmaceutical Formulations ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Liquid Chromatographic Method ◽  
Spiked Plasma ◽  
Liquid Chromatographic

Abstract Zafirlukast (ZAF) is a leukotriene receptor antagonist used in the treatment of chronic asthma. In this study, a simple and sensitive reversed-phase, high-performance liquid chromatographic method was developed for the determination of ZAF in pharmaceutical formulations and human plasma. Piribedil was used as an internal standard. Analysis was carried out on a Nucleosil C18 100 Å(150 × mm 4.6 mm id, 5 ωm) column with acetonitrilepH 3.0 acetate buffer (70 30, v/v) as the mobile phase at a flow rate of 0.8 mL/min. The peak was detected by an ultraviolet detector set at a wavelength of 240 nm. The retention times were about 3.9 min for piribedil and 5.8 min for ZAF. The developed method was applied to the determination of ZAF in its pharmaceutical formulation and spiked human plasma. For quantification of ZAF in spiked plasma, proteins were precipitated with ethanol before chromatographic analysis. The calibration range was linear from 49.69437.50 ng/mL in spiked plasma. The absolute recovery from spiked plasma was 98.73 ± 0.42% at a concentration of 254.78 ng/mL of ZAF. No endogenous substances from plasma were found to interfere.

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