Determination of Meloxicam in Dog Plasma by HPLC and Its Application in Bioeqivalence Study
A promising detection approach,based on protein precipitation method coupled by high performance liquid chromatograph,was established for determination of meloxicam in dog plasma and used in pharmacokinetics and bioequivalence study.Meloxicam was effectively extracted by acetonitrile and separated at the Agilent SB C18 column(150 mm ×4.6 mm,5 μm)using acetonitrile-1％formic acid water(80∶20,V∶V)as the mobile phase.The UV detector was 355 nm.In a randomized crossover study,18 healthy dogs were administered domestic and imported meloxicam at the dose of 0.2 mg/kg·bw with subcutaneous injection.The results indicated that meloxicam in plasma had a good linear relationship in the range of 0.050～3.2 µg/mL(R2 ≥0.999).The intra-and inter-batch precisions were both less than 12％,the average recoveries was 98.7％～108.2％for spiked plasma,plasma samples were stable during different storage condition.All meet the requirements for analysis and detection.The 90％confidence intervals of AUC0-t,AUC0-∞ and Cmax of the meloxicam injection test preparation after a single dose of subcutaneous injection were within the range of 80.00％～125.00％of the corresponding parameters of the reference preparation.The test preparation and the reference preparation were bioequivalent.The results showed that the established method was accurate,sensitive,selective and reproducible,and suitable for the bioequivalence study of meloxicam injection in dogs.
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维普
