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1 2012

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Development, validation, and pharmacokinetic application of liquid chromatographic method for estimation of raloxifene hydrochloride in rabbit plasma

Ravi P. R, Aditya N, Vats R

Acta Chromatographica

2012

Vol. 24, no. 4

559--573

A rapid and sensitive reverse-phase liquid chromatographic method using ultraviolet detector was developed and validated for estimation of raloxifene hydrochloride in rabbit plasma. Plasma samples were extracted using simple protein precipitation-extraction method. The method was developed under isocratic conditions using a Zorbax SB-C8 analytical column with optimum mobile phase composition of 20 mM pH-4.5 ammonium acetate buffer-acetonitrile (63:37 υ/υ) at a flow rate of 1 mL min-1. The detector response was found to be linear in the concentration range of 50–1500 ng mL-1. High recoveries ranging from 97.2% to 100.2% were obtained, which precludes the use of internal standard. The developed method was found to be accurate, precise, and selective in the estimation of raloxifene hydrochloride in rabbit plasma based on the results of method validation carried out as per standard guidelines. The drug was found to be stable under various processing and storage conditions. The developed method was successfully applied in the estimation of raloxifene hydrochloride and the determination of various pharmacokinetic parameters post-intravenous bolus administration of drug in rabbits.