Bioanalytical Method Development and Validation for the Simultaneous Estimation of Citicoline and Piracetam in Human Plasma by HPLC
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Author:
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UPLOADED BY-ADMIN, N. M. JAGANI, J. S. SHAH, P. B. PATEL
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Abstract:
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The study presents the development and validation of a simple RP-HPLC method for the simultaneous determination of Citicoline and Piracetam in human plasma, separation followed by UV detection (PDA detector) performed on deproteinised plasma samples was chosen for the determination of Citicoline and Piracetam. The HPLC method used a Kromasil 100-5 C18 column, 250 mm L × 4.6 mm i.d. column with a gradient elution (1 mL/min) at 26° ± 2oC column temperature. The mobile phase was Water: Acetonitrile (94:6 v/v) gradient elution. The eluent was monitored at 216 nm. The retention time of Citicoline and Piracetam was found to be 4.41 and 5.83 min respectively. The method was developed in terms of accuracy, precision, linearity, specificity, system suitability, and stability studies, limit of detection, limit of quantification, ruggedness and robustness. The calibration curve was linear within the range of 5-30 µg/mL (r2=0.9992, n=5) for Citicoline and 4-24 µg/mL (r2=0.9994, n=5) for Piracetam. The lowest limit of quantification was 0.94 µg/mL for Citicoline and 0.85 µg/mL for Piracetam. The proposed method was validated and proved to be adequate for the simultaneous determination of Citicoline and Piracetam in human plasma.
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Keyword:
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Citicoline, Piracetam, Bioanalytical, RP-HPLC, Human plasma, Validation
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DOI:
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