基于HPLC-MS/MS的2种乙酰氨基阿维菌素注射剂在兔体内的药代动力学对比研究

doi:10.16431/j.cnki.1671-7236.2025.05.033

Abstract

Abstract: 【Objective】 The purpose of the experiment to develop a high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the determination of eprinomectin (EPR) in rabbit plasma,and to compare the pharmacokinetics of two EPR injections in commercial rabbits,so as to provide support for subsequent formulation development.【Method】 12 healthy New Zealand rabbits,half male and half female,were divided into a reference preparation (marketed EPR injection) group and a test preparation (self-developed EPR extended-release injection) group.After subcutaneously injecting the same dose of the two preparations,the plasma samples were collected at different time points.The concentration of EPR was determined by HPLC-MS/MS using moxidectin as an internal standard.The specificity,detection limit,quantification limit,standard curve,accuracy and precision,matrix effect and stability of the established method were investigated.The actual sampling concentration-time data were analyzed with the software Phoenix WinNonlin for non-compartmental model with a weight of 1/Y,and the pharmacokinetic parameters of the two formulations in rabbits were obtained.【Result】 The limit of detection and the limit of quantitative were 0.5 and 1 ng/mL,respectively.The standard curve had a good linear relationship in the range of 1-200 ng/mL with a correlation coefficient (R²) ＞0.99.The intra-assay and inter-assay accuracies of the four concentrations were in the range of 93.70% to 107.73%,and the intra-assay and inter-assay RSDs were all less than 15%.The results showed that the peak time (T_max) of EPR in the reference preparation and the test preparation was (0.39±0.09) and (0.22±0.04)d respectively,the peak concentrations (C_max) were (112.82±29.40) and (30.86±5.11)ng/mL,the half-lives (t_1/2) was (7.14±0.58) and (22.15±1.22)d respectively,the area under the drug time curves (AUC_0→∞) were (420.55±21.74) and (300.65±13.62) ng·d/mL,the mean retention time (MRT) was (3.74±0.80) and (41.62±9.04)d,respectively.【Conclusion】 The results showed that the established HPLC-MS/MS method was sensitive,accurate,stable and reliable,and could be used for the determination of EPR in rabbit plasma samples.The two preparations differed significantly in the rate and extent of absorption as well as in the rate of elimination.The test formulation significantly prolonged the presence of EPR in rabbit plasma compared to the reference formulation.

Key words: eprinomectin; high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS); pharmacokinetics; extended-release injection

CLC Number:

S859.79⁺5

ZHANG Hechao, ZHANG Zhendong, LIU Xiwang, YANG Yajun, LI Shihong, QIN Zhe, LI Jianyong. Comparative Study on Pharmacokinetics of Two Eprinomectin Injections in Rabbits by HPLC-MS/MS[J]. China Animal Husbandry and Veterinary Medicine, 2025, 52(5): 2295-2304.

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Comparative Study on Pharmacokinetics of Two Eprinomectin Injections in Rabbits by HPLC-MS/MS

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