基于HPLC法测定五氯柳胺阿苯达唑复方混悬液中的有关物质

doi:10.16431/j.cnki.1671-7236.2019.11.033

Abstract

Abstract: The purpose of experiment was established a high performance liquid chromatography (HPLC) method to determine the related substances of oxyclozanide and albendazole compound suspension.A HPLC was used to determine the related substances of oxyclozanide and albendazole in the compound suspension by self-contrast method.The chromatographic separeation was performed using a Thermo Hypersil BDS C18 column (4.6 mm×150 mm,5 μm) at 30℃.The mobile phase consisted of water containing 0.1% phosphoric acid and 10 mmol/L ammonium dihydrogen phosphate (A) and methanol (B) at a constant ratio of 31:69 (V/V) and a flow rate of 1 mL/min.The detection wavelength was 295 nm,and the injection volume was 5 μL.Under the above chromatographic conditions,the peaks of oxyclozanide,albendazole and impurity peaks could be completely separated.The good linear relationships for peak area for 3,5,6-trichlorosalicylic acid,2-amino-4,6-dichlorophenol hydrochloride,oxyclozanide and albendazole were obtained in the range of 5 to 100 μg/mL (R² ≥ 0.999).LOQ were 5 μg/mL,750 ng/mL,500 ng/mL and 225 ng/mL,respectively.LOD were 1 μg/mL,500 ng/mL,250 ng/mL and 100 ng/mL,respectively.The average recovery of 3,5,6-trichlorosalicylic acid and 2-amino-4,6-dichlorophenol hydrochloride were 101.15% (RSD was 0.71%) and 100.35% (RSD was 0.71%),respectively.The validation results showed that the HPLC method was simple,rapid and accurate,and could be used to the related substances of oxyclozanide and albendazole compound suspension.

Key words: oxyclozanide; albendazole; compound preparations; related substances; HPLC

CLC Number:

S852.65⁺9.1

LI Xiaoting, BAI Yubin, LI Bing, DONG Zhen, SUN Jichao, CHENG Fusheng, ZHANG Jiyu. Determination of Related Substances in Oxyclozanide and Albendazole Compound Suspension by HPLC[J]. China Animal Husbandry and Veterinary Medicine, 2019, 46(11): 3422-3431.

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Determination of Related Substances in Oxyclozanide and Albendazole Compound Suspension by HPLC

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