Silybin (SBN) is a major active constituent of silymarin, a mixture of flavonoids found in\nfruits and seeds of milk thistle. The aim of this study was to describe a simple bioanalytical method\nfor quantifying SBN in rat plasma. A simple protein deproteinization procedure with acetonitrile\n(ACN) was employed for plasma sample preparation. A reversed column and gradient elution of\na mobile phase (mixture of phosphate buffer (pH 5.0) and ACN) were used for chromatographic\nseparation. The selectivity, linearity (50-500 ng/mL), precision, accuracy, recovery, matrix effect,\nand stability for this method were validated as per the current Food and Drug Administration\n(FDA) guidelines. Our method for SBN was applied to a comparative pharmacokinetic study on\nfour different commercial silymarin products. This in vivo rat study demonstrated that product\n#4 significantly enhanced the relative oral bioavailability of SBN, as compared to product #1-3.\nTherefore, the bioanalytical method proposed herein could serve as a promising alternative for\npreclinical pharmacokinetic studies on silymarin products and, by extension, clinical use after partial\nmodification and validation.
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