Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulat...Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulation. The drug separation was performed on Hibar-240, Li-chrosphere-100 C18 ODS (250 × 4.6 mm, 5 μm) column, at a flow rate of 1 mL/min. The mobile phase used was a mixture of methanol: potassium di-hydrogen phosphate buffer at a ratio of 70:30 v/v. The detection was carried out at a wavelength of 266 nm. The retention times of sitagliptin phosphate and metformin hydrochloride were found as 6.1 and 4.9 min respectively. Linear calibration curves with good correlation coefficients were obtained over the concentration ranges of 10 - 50 μg/mL for sitagliptin and 20 - 100 μg/mL for metformin. The limit of detection was 0.016 and 0.14 μg/mL and the limit of quantification was 0.048 and 0.42 μg/mL for sitagliptin phosphate and metformin hydrochloride respectively. Validation of the method demonstrated system selectivity, specificity, linearity, accuracy and precision. The developed method was found useful in the simultaneous analysis of sitagliptin phosphate and metformin hydrochloride in formulation.展开更多
通用技术文件(common technical document,CTD)和电子通用技术文件(electronic common technical documents,e CTD)是国际人用药品注册技术协调会(international council for harmonisation of technical requirements for pharmaceutic...通用技术文件(common technical document,CTD)和电子通用技术文件(electronic common technical documents,e CTD)是国际人用药品注册技术协调会(international council for harmonisation of technical requirements for pharmaceuticals for human use,ICH)的重要工作成果,为规范药品注册文件格式,提高药品审评速度和效率起着至关重要的作用。本文简单介绍CTD和eCTD的背景,以及药品注册文件递交方式的发展历程,即纸质递交到电子递交、电子递交的3种方式(PDF、非eCTD和eCTD)。最后,系统介绍了eCTD格式注册文件的编辑程序,即创建文件夹、PDF文件转换、XML文件的创建、验证和递交,希望可以为国内企业和药品监管机构系统了解eCTD提供参考。展开更多
文摘Present study was aimed to develop and validate a reverse-phase high-performance liquid chromatography method for simultaneous determination of sitagliptin phosphate and metformin hy-drochloride in a marketed formulation. The drug separation was performed on Hibar-240, Li-chrosphere-100 C18 ODS (250 × 4.6 mm, 5 μm) column, at a flow rate of 1 mL/min. The mobile phase used was a mixture of methanol: potassium di-hydrogen phosphate buffer at a ratio of 70:30 v/v. The detection was carried out at a wavelength of 266 nm. The retention times of sitagliptin phosphate and metformin hydrochloride were found as 6.1 and 4.9 min respectively. Linear calibration curves with good correlation coefficients were obtained over the concentration ranges of 10 - 50 μg/mL for sitagliptin and 20 - 100 μg/mL for metformin. The limit of detection was 0.016 and 0.14 μg/mL and the limit of quantification was 0.048 and 0.42 μg/mL for sitagliptin phosphate and metformin hydrochloride respectively. Validation of the method demonstrated system selectivity, specificity, linearity, accuracy and precision. The developed method was found useful in the simultaneous analysis of sitagliptin phosphate and metformin hydrochloride in formulation.
文摘通用技术文件(common technical document,CTD)和电子通用技术文件(electronic common technical documents,e CTD)是国际人用药品注册技术协调会(international council for harmonisation of technical requirements for pharmaceuticals for human use,ICH)的重要工作成果,为规范药品注册文件格式,提高药品审评速度和效率起着至关重要的作用。本文简单介绍CTD和eCTD的背景,以及药品注册文件递交方式的发展历程,即纸质递交到电子递交、电子递交的3种方式(PDF、非eCTD和eCTD)。最后,系统介绍了eCTD格式注册文件的编辑程序,即创建文件夹、PDF文件转换、XML文件的创建、验证和递交,希望可以为国内企业和药品监管机构系统了解eCTD提供参考。
