Determination of Serum Concentration of Ganciclovir in Dogs and Study on Relative Bioavailability of Ganciclovir Dispersible Tablets
Meng De-sheng
Abstract
Meng De-sheng
Abstract
OBJECTIVE:To establish an HPLC method for determination of ganciclovir in serum of dogs and to study pharmacokinetics and relative bioavailability of Ganciclovir dispersible tablets.METHODS:The determination was performed on Dikma DiamonsilTM C18 column.The mobile phase consisted of 0.015 mol·mL-1 monobasic potassium phosphate buffer solution (pH 2.50,containing 0.25% acetonitrile) with flow rate of 1.75 mL·min-1 at detection wavelength of 254 nm.The column temperature was set at 40 ℃.In a randomized cross-over study,a single dose of dispersible tablets and the capsule were given to 6 dogs.An HPLC method was used to determine plasma concentration of ganciclovir in dogs and the pharmacokinetic data were treated by DASver1.0 software.RESULTS:The linear range of ganciclovir were 0.050 25~100.5 μg·mL-1;the methodological recovery was larger than 90% (RSD4%).The pharmacokinetics parameters of Ganciclovir dispersible tablets and Ganciclovir capsules were as follows:Cmax:(50.91±13.36) μg·mL-1 vs.(42.27±14.69) μg·mL-1;tmax:(2.70±0.67) h vs.(3.20±0.57) h;AUC0~24:(361.50±72.76) μg·h·mL-1 vs.(280.60±101.87) μg·h·mL-1.The relative bioavailability of Ganciclovir dispersible tablets was 128.83%.CONCLUSION:The established method is sensitive,specific and can be used for the pharmacokinetic studies.The dispersible tablet was bioequivalent to the capsule in absorption speed but not in absorption rate.
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OBJECTIVE:To establish an HPLC method for determination of ganciclovir in serum of dogs and to study pharmacokinetics and relative bioavailability of Ganciclovir dispersible tablets.METHODS:The determination was performed on Dikma DiamonsilTM C18 column.The mobile phase consisted of 0.015 mol·mL-1 monobasic potassium phosphate buffer solution (pH 2.50,containing 0.25% acetonitrile) with flow rate of 1.75 mL·min-1 at detection wavelength of 254 nm.The column temperature was set at 40 ℃.In a randomized cross-over study,a single dose of dispersible tablets and the capsule were given to 6 dogs.An HPLC method was used to determine plasma concentration of ganciclovir in dogs and the pharmacokinetic data were treated by DASver1.0 software.RESULTS:The linear range of ganciclovir were 0.050 25~100.5 μg·mL-1;the methodological recovery was larger than 90% (RSD4%).The pharmacokinetics parameters of Ganciclovir dispersible tablets and Ganciclovir capsules were as follows:Cmax:(50.91±13.36) μg·mL-1 vs.(42.27±14.69) μg·mL-1;tmax:(2.70±0.67) h vs.(3.20±0.57) h;AUC0~24:(361.50±72.76) μg·h·mL-1 vs.(280.60±101.87) μg·h·mL-1.The relative bioavailability of Ganciclovir dispersible tablets was 128.83%.CONCLUSION:The established method is sensitive,specific and can be used for the pharmacokinetic studies.The dispersible tablet was bioequivalent to the capsule in absorption speed but not in absorption rate.
Key concepts: Ganciclovir, Bioavailability, Pharmacokinetics, Cmax, Chromatography, High-performance liquid chromatography, Capsule, Bioequivalence