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DEVELOPMENT AND VALIDATION OF A BIOANALYTICAL METHOD FOR DETERMINATION OF QUETIAPINE FROM HUMAN PLASMA

Keywords: Quetiapine , human plasma , HPLC , bioanalytical method validation.

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Abstract:

A simple high-performance liquid chromatographic (HPLC) method for the analysis of the antipsychotic drug quetiapine fumarate in human plasma has been developed. Zolpidem tartrate was employed as the internal standard (IS). Biological samples were pretreated by liquid-liquid extraction (LLE) technique using tert-butyl methyl ether (TBME). Separation was performed on a HiQSil C18HS (250x4.6 mm, 5μm) column. The mobile phase used was Acetonitrile-ammonium acetate buffer (pH 3.5, 10 mM) (40:60 v/v) pumped at a flow rate of 1 mL/min. Samples were injected by means of an autosampler via a variable loop and detected using UV detector at a wavelength of 254 nm. A good linearity was found in the concentration range of 100-2000 ng/mL. Within and between batch precision and accuracy of the proposed method were evaluated by percent relative standard deviation (% R.S.D.) and percent relative error (% RE) respectively; both being within the acceptable limits. The method was also validated for recovery, carry-over and stability. Freeze and thaw stability, short term stability and long term stability were evaluated for the developed bioanalytical method. The described method can be applied for quantitation of quetiapine in real clinical samples.

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