摘要
目的建立自制羧甲司坦微囊中羧甲司坦的含量测定方法,为羧甲司坦微囊处方、制备工艺的优化提供实验依据。方法采用紫外分光光度法在567 nm波长处测定,以茚三酮作为显色剂;高效液相色谱法采用WondaCract ODS-2 C18柱(250 mm×4.6 mm,5μm),流动相:pH 6.6磷酸盐缓冲溶液,检测波长:210 nm,流速:1 mL/min,柱温:35℃。结果紫外分光光度法:羧甲司坦微囊在32.10~80.24μg/mL范围内线性良好(R2=0.9990)。精密度、重复性、稳定性的相对标准偏差(RSD)均小于10%,平均回收率96.65%,RSD为1.48%。三批自制羧甲司坦微囊平均含量在34.60%以上。高效液相色谱法:羧甲司坦微囊在4.08~28.56μg/mL范围内线性良好(R2=0.9994)。精密度、重复性、稳定性的RSD均小于2%,平均回收率95.01%,RSD为1.90%。三批自制羧甲司坦微囊平均含量在43.22%以上。结论所建立的方法准确可靠,为该制剂的质量控制提供了实验依据,可用于羧甲司坦微囊含量的测定。
Objective To establish determination method of the content of the self-made carbocisteine microcapsules,and provide experimental basis for the optimization of the prescription and preparation process of carbocisteine microcapsules.Methods The wavelength of ultraviolet spectrophotometry was 567 nm,and ninhydrin was used as chromogenic agent.The WondaCract ODS-2 C18(250×4.6 mm,5μm)column was used,mobile phase was pH 6.6 phosphate buffer solution,detection wavelength was 210 nm,mobile phase volume flow rate was 1 mL/min,and column temperature was 35°C.Results The carbocisteine microcapsules were linear in the range of 32.10~80.24μg/mL by ultraviolet spectrophotometry,and the linear correlation coefficient was good(R 2=0.9990).The relative standard deviation(RSD)of precision,repeatability and stability was less than 10%,the average recovery rate was 96.65%,and the RSD was 1.48%.The average content of the three batches of self-made carbocisteine microcapsules were more than 34.60%.High performance liquid chromatography the carbocisteine microcapsules were linear in the range of 4.08~28.56μg/mL,and the linear correlation coefficient was good(R 2=0.9994).The relative standard deviation(RSD)of precision,repeatability and stability were less than 2%,and the average recovery rate was 95.01%,and the RSD was 1.90%.The average content of the three batches of self-made carbocisteine microcapsules were more than 43.22%.Conclusion The established method is accurate and reliable,which provided the experimental basis for the quality control of the preparation and can be used for the determination of carbocisteine microcapsules.
作者
颜元
刘傲
杨成
刘丽娜
王磊
黄静
Yan Yuan;Liu Ao;Yang Cheng;Liu Lina;Wang Lei;Huang Jing(Department of Pharmacy,School of Pharmaceutical Sciences,Guizhou Medical University,Guiyang 550025,Guizhou,China.)
出处
《贵州医药》
CAS
2023年第5期678-681,共4页
Guizhou Medical Journal
基金
国家级大学生创新创业训练计划项目(编号:202110660021)。
关键词
羧甲司坦
微囊
紫外分光光度法
高效液相色谱法
含量测定
Carbocisteine
Microcapsule
Ultraviolet spectrophotometry
High performance liquid chromatography
Content determination
