Epalrestat is a new drug for diabetic neuropathy. A new, simple, rapid very sensitive, and accurate high performance thin-layer chromatographic (HPTLC) method has been developed and validated for estimation of epalrestat in plasma. HPTLC was performed on silica gel 60F 254 plates with ethyl acetate-toluene-acetic acid, 60 + 40 + 2 (v/v), as mobile phase. Nitrofurantoin was used as internal standard. Densitometric scanning was performed in absorbance mode at λ λ = 390 nm. The R F values of the internal standard and drug were 0.4 and 0.6, respectively. The response was a linear function of concentration over the range 0.1-6.0 μg mL -1 (r 2 = 0.9974). Mean extraction recovery was >63%. Intra-day and inter-day precision (% CV) of the assay were in the range 1.62-4.68% and accuracy was >95%. This method can be applied to pharmacokinetic and bioequivalence studies. Preparation of Calibration Standard Solutions in PlasmaCalibration standards were prepared by spiking drug-free plasma with epalrestat working standard solution (100 μg mL -1 , 60 μL) to furnish a 6 μg mL -1 calibration standard. This solution was further diluted with drug-free plasma to furnish calibration
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