Фармацевтика Аналитика Акта

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Micellar High Performance Liquid Chromatographic Determination of a Binary Mixture of Rivaroxaban and Clopidogrel and Application to Biological Fluids

Heba Abd El-Aziz, Ibrahim F, Sharaf El-Din M and Fathy ME

A selective and short time consuming cost effective micellar high performance liquid chromatographic technique is created for the separation and simultaneous assay of two antiplatelet drugs, Rivaroxaban (RIV) with Clopidogrel (CLP). The developed and validated method is characterized by its simplicity, sensitivity and rapidness. Chromatographic study is performed on a 3 mm × 4.6 mm i.d., 2 μm pore size highly porous monolithic (chromolith® reversed phase) column to obtain good chromatographic separation using a mixture of 0.185 M sodium dodecyl sulphate (SDS), 8% n-propanol, 0.3% triethylamine (TEA) as a mobile phase, adjusted at pH 4.0 using 0.02 M orthophosphoric acid and pumped at a flow rate of 1 mL/min. using UV detector at 235 nm. The internal standard (IS) of choice was Raloxifen (RAL) and separation was performed at room temperature. Good linearity for the proposed method was obtained over the ranges of 0.3-9.0 μg/mL and 0.5-25.0 μg/mL with limits of detection (LOD) of 0.05, 0.16 μg/mL and limits of quantitation (LOQ) of 0.16, 0.49 μg/mL for rivaroxaban and clopidogrel, respectively and retention time was 1.9 and 5min., respectively. Simultaneous analysis of the studied drugs in their laboratory prepared mixture and tablet was done as an application for the proposed method showing satisfactory results. Also biological fluids were assayed using the proposed method for the determination of rivaroxaban in human plasma and for both drugs in human urine with no need for previous extraction. The data obtained by the proposed method was statistically evaluated and compared with the reference one showing good accuracy and precision of the proposed method.