The elemental impurities in pharmaceutical products have aroused widespread concern among respective supervising authorities and official pharmacopoeias since they are harmful and have no therapeutic effects. Metronidazole benzoate is used extensively to treat a variety of infections. However, impurities will inevitably be introduced in the manufacturing process of metronidazole benzoate. Hence, in this study, a sensitive method was developed for trace determination of elemental impurities in metronidazole benzoate active pharmaceutical ingredients by using inductively coupled plasma mass spectrometry in kinetic energy discrimination mode. The method was validated for system suitability, specificity, linearity, sensitivity, accuracy, and precision according to USP chapter <233> Elemental Impurities-Procedure. The method had good linearity with correlation coefficients > 0.99. The limits of detection were in the range of 0.0003-0.1411 mu g/g, which was lower than the acceptable limit and indicated the high sensitivity of the method. The method was accurate with the recoveries in the range of 92%-107%. Moreover, the content of seven elemental impurities in the three batches of metronidazole benzoate active pharmaceutical ingredients by this method was originally below their limits and less than 30% of permitted daily exposure, meeting the requirement of International Council for Harmonization Q3D guidelines. Thus, this newly developed and validated method for estimating elemental impurities in metronidazole benzoate active pharmaceutical ingredients was within the permitted limit and suitable for routine use.
语种:
外文
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2023]版:
大类|4 区化学
小类|4 区物理:原子、分子和化学物理4 区光谱学
最新[2025]版:
大类|4 区化学
小类|4 区物理:原子、分子和化学物理4 区光谱学
JCR分区:
出版当年[2022]版:
Q3SPECTROSCOPYQ4PHYSICS, ATOMIC, MOLECULAR & CHEMICAL
最新[2023]版:
Q3SPECTROSCOPYQ4PHYSICS, ATOMIC, MOLECULAR & CHEMICAL
第一作者单位:[1]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Dept Pharm, Wuhan 430030, Peoples R China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Tian Maoxian,Zhang Hui,Fan Huajun,et al.Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry[J].EUROPEAN JOURNAL OF MASS SPECTROMETRY.2024,30(1):60-64.doi:10.1177/14690667231211696.
APA:
Tian, Maoxian,Zhang, Hui,Fan, Huajun,Yin, Mingxing,Wang, Wenqing&Shi, Chunyang.(2024).Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry.EUROPEAN JOURNAL OF MASS SPECTROMETRY,30,(1)
MLA:
Tian, Maoxian,et al."Method for determination of elemental impurities in metronidazole benzoate using inductively coupled plasma mass spectrometry".EUROPEAN JOURNAL OF MASS SPECTROMETRY 30..1(2024):60-64