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Determination and Pharmacokinetic Study of Pirfenidone in Rat Serum by High-Performance Thin-Layer Chromatography
Sonali G Thorat1, Rupesh V Chikhale2
1Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur 440 033, MS, India.
Abstract:
A rapid, sensitive and selective high-performance thin-layer chromatography (HPTLC) method was developed and validated for the determination and pharmacokinetics of pirfenidone in rat serum. One-step protein precipitation by methanol is reported, and serum samples were separated by HPTLC using a simple mobile phase of toluene-methanol in the ratio of 8:2. The retardation factor of pirfenidone in the serum sample was 0.45 with the detection performed at 315 nm. The calibration curve was linear over the range of 100-1,200 ng/spot with a lower limit of quantitation of 40 ng/spot. The mean recovery of pirfenidone in serum was in the range of 70.6-75.8%, and intra-day and inter-day precision were both <14.1%. This method was successfully applied to the pharmacokinetic study of pirfenidone in rats on oral administration of the drug at a dose of 15.0 mg/kg.
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