乙酰氨基阿维菌素缓释注射剂中乙酰氨基阿维菌素含量与有关物质HPLC检测方法的建立

doi:10.16431/j.cnki.1671-7236.2021.12.036

Abstract

Abstract: The study was designed to develop an HPLC method for the determination of the content of the principal ingredient and related substances in eprinomectin (EPR) sustained-release injection.The external standard method and self-control method were utilized for calculating the content of the principal ingredient and related substances, respectively.The chromatographic column of the content and related substances was Phenomenex Luna 5 μ-C8-100A 250 mm×4.60 mm, 5 μm.The detection method was as followed:Acetonitrile-0.1% aqueous perchloric acid solution with gradient, the flow rate was 1.5 mL/min, the detection wavelength was 245 nm, the column temperature was 35 ℃, and the injection volume was 20 μL.The results showed that the principal component of EPR was well separated with the peak of related substances, the degree of separation between B1a and B1b was greater than 3.The linear relationship was good when the concentration of EPR was 1.5625-1 000 μg/mL.The detection and quantification limit of EPR were 0.01 and 0.34 μg/mL, respectively.RSD of the three kinds of precision was less than 2%, RSD of stability test was 0.28%, average recovery was 102.54%, and RSD was 3.14% (n=9).The robustness showed that the resolution of the principal components of EPR sustained-release injection was more than 1.5, and the number of theoretical plates was more than 4 500.The results showed that the detection conditions were durable.In 3 batches, average value of EPR was 102.60%, B1b accounts for 1.68% of the sum of B1a and B1b, total impurity were 2.57%.All the results suggested that the optimized HPLC method in this study was simple, specific, sensitive, accurate, and suitable for quality control of EPR sustained-release injection.

Key words: eprinomectin (EPR); HPLC; content determination; related substance

CLC Number:

S859.79⁺5

GENG Xiang, LIU Xiwang, YANG Yajun, LI Jianyong. Establishment of HPLC Method for Determination of Eprinomectin and Related Substances in Eprinomectin Sustained-release Injection[J]. China Animal Husbandry and Veterinary Medicine, 2021, 48(12): 4681-4689.

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Establishment of HPLC Method for Determination of Eprinomectin and Related Substances in Eprinomectin Sustained-release Injection

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