An LC-MS/MS method for the quantification of diclofenac sodium in dairy cow plasma and its application in pharmacokinetics studies

Biomedical Chromatography : BMC
Ya-Jun YangJian-Yong Li

Abstract

An LC-MS/MS method with internal standard tolfenamic acid for determining diclofenac sodium (DCF) in dairy cow plasma was developed and validated. Samples were processed with protein precipitation by cold formic acid-acetonitrile. Determination of DCF was performed using LC-ESI+ -MS/MS with the matrix-matched calibration curve. The results showed that the method was sensitive (LOD 2 ng mL-1 , LOQ 5 ng mL-1 ), accurate (97.60 ± 5.64%), precise (<10%) and linear in the range of 5-10,000 ng mL-1 . A single intravenous (i.v.) or intramuscular (i.m.) administration of 5% diclofenac sodium injection at a dose of 2.2 mg kg-1 was performed in six healthy dairy cows according to a two-period crossover design. The main pharmacokinetic (PK) parameters after a single i.v. administration were as follows: t1/2β , 4.52 ± 1.71 h; AUC, 77.79 ± 16.76 h μg mL-1 ; mean residence time, 5.16 ± 1.11 h. The main PK parameters after a single i.m. administration were as follows: Tmax , 2.38 ± 1.19 h; Cmax , 7.46 ± 1.85 μg mL-1 ; t1/2β , 9.46 ± 2.86 h; AUC 67.57 ± 13.07 h μg mL-1 . The absolute bioavailability was 87.37 ± 5.96%. The results showed that the diclofenac sodium injection had PK characteristics of rapid absorption and slow elimination, and hi...Continue Reading

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