Identification and structural characterization of four novel degradation products and a process impurity of isavuconazonium sulfate for injection formulation bulk by LC-ESI-QTOF-MS/MS

被引：2
|
作者：
Regella, Venkata Rama Prabhakara Sastry [1 ]
Subramanian, Venkatesan Chidambaram [1 ]
Bhetanabhotla, Sarveswara Sastry [1 ]
机构：
[1] Gland Pharma Ltd, Res & Dev, Hyderabad 500043, Telangana, India
来源：
EUROPEAN JOURNAL OF MASS SPECTROMETRY | 2020年 / 26卷 / 02期
关键词：
Characterization; degradation products; isavuconazonium sulfate; LC-PDA; MS; tandem mass spectrometry; degradation profile; PRODRUG;
D O I：
10.1177/1469066719884402
中图分类号：
O64 [物理化学（理论化学）、化学物理学]; O56 [分子物理学、原子物理学];
学科分类号：
070203 ; 070304 ; 081704 ; 1406 ;
摘要：
Isavuconazonium sulfate is a highly water-soluble pro-drug of active triazole isavuconazole. The degradation profile of isavuconazonium sulfate for injection formulation bulk under acid hydrolysis, alkaline hydrolysis, oxidation, heat, and light conditions was studied using LC-PDA/MS technique. Four degradation products (DP1 to DP4) and one process impurity (PI1) were identified in isavuconazonium sulfate formulation bulk and characterized the identified impurities by liquid chromatography-electron spray ionization-quadruple-time of flight tandem mass spectrometry. Isavuconazole (DP1) was found to be one of the major degradation products of isavuconazonium sulfate.
引用
收藏
页码：144 / 152
页数：9
相关论文
共 50 条
  • [1] Identification and structural characterization of four novel degradation products and a process impurity of isavuconazonium sulfate for injection formulation bulk by LC-ESI-QTOF-MS/MS
    Regella, Venkata Rama Prabhakara Sastry (sastryrvrp@glandpharma.com), 1600, SAGE Publications Ltd (26):
  • [2] Development of Stability Indicating Assay Method for Separation and Identification of Degradation Products of Daclatasvir Dihydrochloride by LC-ESI-QTOF-MS/MS
    Swain, Debasish
    Yadav, Amrej Singh
    Akula, Venkatakrishna
    Pamidi, Srinivasu
    Samanthula, Gananadhamu
    ANALYTICAL CHEMISTRY LETTERS, 2019, 9 (02) : 209 - 222
  • [3] Study of degradation behavior of besifloxacin, characterization of its degradation products by LC-ESI-QTOF-MS and their in silico toxicity prediction
    Salunke, Nishant
    Kharkar, Prashant S.
    Pandita, Nancy
    BIOMEDICAL CHROMATOGRAPHY, 2019, 33 (06)
  • [4] Inherent stability testing of empagliflozin in the presence of metformin HCl by HPTLC and characterization of degradation products of empagliflozin by LC-ESI-QTOF-MS/MS
    Vichare, Vijaya
    Choudhari, Vishnu
    Tambe, Vrushali
    Dhole, Shashikant
    JPC-JOURNAL OF PLANAR CHROMATOGRAPHY-MODERN TLC, 2022, 35 (01) : 61 - 71
  • [5] Structural characterization of alkaline and oxidative stressed degradation products of lurasidone using LC/ESI/QTOF/MS/MS
    Talluri, M. V. N. Kumar
    Dharavath, Shireesha
    Kalariya, Pradipbhai D.
    Prasanth, B.
    Srinivas, R.
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2015, 105 : 1 - 9
  • [6] Identification and structural characterization of hydrolytic degradation products of alvimopan by LC/QTOF/MS/MS and NMR studies
    Baira, Shandilya Mahamuni
    Srinivas, R.
    Talluri, M. V. N. Kumar
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2019, 165 : 399 - 409
  • [7] LC-ESI-QTOF-MS/MS Identification and Characterization of Phenolic Compounds from Leaves of Australian Myrtles and Their Antioxidant Activities
    Ali, Akhtar
    Mueed, Abdul
    Cottrell, Jeremy J.
    Dunshea, Frank R.
    MOLECULES, 2024, 29 (10):
  • [8] Screening and characterization of phenolic compounds by LC-ESI-QTOF-MS/MS and their antioxidant potentials in papaya fruit and their by-products activities
    Zhou, Yufeng
    Cao, Yuanxiao
    Li, Jiaxun
    Agar, Osman Tuncay
    Barrow, Colin
    Dunshea, Frank
    Suleria, Hafiz A. R.
    FOOD BIOSCIENCE, 2023, 52
  • [9] A study on structural characterization of degradation products of cangrelor using LC/QTOF/MS/MS and NMR
    Guvvala, Vinodh
    Subramanian, Venkatesan Chidambaram
    Anireddy, Jaya Shree
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2019, 170 : 327 - 334
  • [10] LC-ESI-QTOF-MS identification of novel antioxidant peptides obtained by enzymatic and microbial hydrolysis of vegetable proteins
    Babini, Elena
    Tagliazucchi, Davide
    Martini, Serena
    Piu, Lucilla Dei
    Gianotti, Andrea
    FOOD CHEMISTRY, 2017, 228 : 186 - 196
12345