title: Quantitative 1H-NMR Method for the Determination of Tadalafil in Bulk Drugs and its Tablets.
abstract: A simple, rapid, accurate, and selective quantitative nuclear magnetic resonance method for the determination of tadalafil in bulk drugs and its tablets was established and evaluated. Spectra were obtained in dimethylsulfoxide-d6 using 2,4-dinitrotoluene as the internal standard. In this study, the method's linearity, range, limit of quantification, stability, precision, and accuracy were validated. The results were consistent with those obtained from high-performance liquid chromatography analysis. Thus, the proposed method is a useful and practical tool for the determination of tadalafil in bulk drugs and its tablets.
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. yqy@imm.ac.cn.
authors.forename: Qingyun
authors.initials: Q
authors.lastname: Yang
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. qiuhui@imm.ac.cn.
authors.forename: Hui
authors.initials: H
authors.lastname: Qiu
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. guowei@imm.ac.cn.
authors.forename: Wei
authors.initials: W
authors.lastname: Guo
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. wangdmchina@imm.ac.cn.
authors.forename: Dongmei
authors.initials: D
authors.lastname: Wang
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. xiaodou_zxn@aliyun.com.
authors.forename: Xingning
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. xuedan0628@126.com.
authors.forename: Dan
authors.initials: D
authors.lastname: Xue
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. zhjl@imm.ac.cn.
authors.forename: Jinlan
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. ws@imm.ac.cn.
authors.forename: Song
authors.initials: S
authors.lastname: Wu
authors.affiliation: Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical Colledge, Beijing 100050, China. wyh@imm.ac.cn.
authors.forename: Yinghong
authors.initials: Y
authors.lastname: Wang
mesh_terms: D002851:Chromatography, High Pressure Liquid; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D058986:Phosphodiesterase 5 Inhibitors / Q000032:analysis*; D066244:Proton Magnetic Resonance Spectroscopy / Q000379:methods*; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry*; D000068581:Tadalafil / Q000032:analysis*
chemical_list: D004364:Pharmaceutical Preparations; D058986:Phosphodiesterase 5 Inhibitors; D013607:Tablets; D000068581:Tadalafil
keywords: 2,4-dinitrotoluene; quantitative analysis; quantitative proton nuclear magnetic resonance; tadalafil