摘要
目的考察紫外-可见分光光度(UV-Vis)法与高效液相色谱(HPLC)法测定阿莫西林胶囊溶出度的差异。方法 UV-Vis法测定波长为272 nm;HPLC法色谱柱为Inertsil ODS C18柱(150 mm×4.6 mm,5μm),流动相为0.05 mol/L磷酸二氢钾溶液(用2 mol/L氢氧化钾溶液调节pH至5.0)-乙腈(97.5∶2.5,V/V),检测波长为254 nm,进样量为20μL,流速为1.0 m L/min。分别以水、pH 1.2的盐酸氯化钠溶液、pH 4.0的醋酸盐缓冲液、pH 6.8的磷酸盐缓冲液为溶出介质,采用篮法(转速为100 r/min)测定原研产品(参比制剂)的体外溶出量。结果测定参比制剂在以上4种溶出介质中120 min时的溶出度,UV-Vis法分别为109.53%,115.64%,110.02%,114.72%,HPLC法分别为102.54%,77.11%,101.09%,102.24%。结论 HPLC法简单、准确,可用于阿莫西林胶囊溶出度的定量测定,且消除了空胶囊壳的干扰,更能真实地反映产品在溶出介质中的溶出度,可用于阿莫西林胶囊的一致性评价。
Objective To investigate the difference in the dissolution of Amoxicillin Capsules determined by ultraviolet visible spectrophotometry(UV-Vis)and high-performance liquid chromatography(HPLC).Methods The UV-Vis method was adopted with detection wavelength of 272 nm.The HPLC method was adopted with Inertsil ODS C18 column(150 mm×4.6 mm,5μm),the mobile phase was 0.05 mol/L monobasic potassium phosphate solution(adjusted pH to 5.0 with 2 mol/L potassium hydroxide solution)-acetonitrile(97.5∶2.5,V/V),the detection wavelength was 254 nm,the injection volume was 20μL,and the flow rate was 1.0 m L/min.The dissolution of the original products(reference preparation)in vitro were determined by basket apparatus(the stirring speed was 100 r/min)with water,pH 1.2 hydrochloric acid sodium chloride solution,pH 4.0 acetate buffer and pH 6.8 phosphate buffer as dissolution medium.Results The dissolution of the reference preparation in the above four dissolution medium within 120 min was 109.53%,115.64%,110.02%,114.72%by UV-Vis method and 102.54%,77.11%,101.09%,102.24%by HPLC method.Conclusion The HPLC method is simple and accurate,which can be used for the quantitative determination of the dissolution of Amoxicillin Capsules and eliminate the interference caused by empty capsule shell.It can reflect the dissolution of the product in the dissolution medium more accurately and can be used for the consistency evaluation of Amoxicillin Capsules.
作者
沈川
程义
曾令高
姜学美
沈丹丹
SHEN Chuan;CHENG Yi;ZENG Linggao;JIANG Xuemei;SHEN Dandan(Chongqing Qijiang District People’s Hospital,chongqing,china 401420;Chongqing Institute for Food and Drug Control,chongqing,china 401121;Chongqing Research Center for Drug Process and Quality Control Engineering,National Medical Products Administration,chongqing,china 401121)
出处
《中国药业》
CAS
2021年第5期59-62,共4页
China Pharmaceuticals
基金
国家科技重大专项-重大新药创制课题资助项目[2017ZX09101001]。
