反相高效液相色谱法测定恩替卡韦口腔速溶膜剂中药物含量

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Abstract Objective To establish a reverse phase high performance liquid chromatography (RP-HPLC) method for the determination of drug content in entecavir-loaded orodispersible films (ODFs). Methods The entecavir-loaded ODFs were prepared by using a solvent casting method with polyvinyl alcohol/polyethylene glycol graft copolymer as a film-forming agent. The RP-HPLC analysis was performed on an Inertsil ODS-3 C18 (4.6 mm×150 mm, 5 μm) column with mobile phases composed of acetonitrile-water (3∶97) and acetonitrile. The flow rate of mobile phase was 1.0 mL/min. The wavelength of UV detector was set at 254 nm and the injection volume was 20 μL. The column temparature was mantained at 25℃. The drug content of entecavir-loaded ODFs was analyzed by a gradient elution mode. Results The linear regression equation of entecavir standard solution was A=52548.1316C-639.5153 (R2=0.9999). The intra-day precision was 0.15%-0.56%, the inter-day precision was 0.35%-1.36%, and the accuracy was 99.70%. The limit of detection was 0.31 ng and the limit of quantitation was 0.28 ng. The drug solution was stable within 24 h. The drug content of entecavir-loaded ODFs was (98.93±0.55)%. Conclusion The RP-HPLC method of entecavir shows high specificity, good precision, accuracy, and stability. This method is suitable for the detemination of drug content in entecavir-loaded ODFs.

Key words： RP-HPLC Entecavir Orodispersible films Polyvinyl alcohol/polyethylene glycol graft copolymer Content determination

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	WEI Teng1 GAO Ying2 CAO Qingri1

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WEI Teng1 GAO Ying2 CAO Qingri1. Determination of drug content in entecavir-loaded orodispersible film by a reverse phase high performace liqiud chromatography[J]. 中国医药导报, 2018, 15(6): 19-23.

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http://www.yiyaodaobao.com.cn/EN/ OR http://www.yiyaodaobao.com.cn/EN/Y2018/V15/I6/19

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