Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib
Joint Authors
Suryanarayana, Mulukutla Venkata
Srinivasulu, Kasa
Naidu, Mopidevi Narasimha
Rajasekhar, Kadaboina
Veerender, Murki
Source
Chromatography Research International
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-13, 13 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2012-08-29
Country of Publication
Egypt
No. of Pages
13
Main Subjects
Abstract EN
A novel, simple, sensitive, stability indicating HPLC method was developed and validated for quantification of impurities (process related and degradants) and assay determination of bortezomib.
Stability indicating power of the method was established by forced degradation experiments and mass balance study.
The chromatographic separation was achieved with Waters SymmetryShield RP18 column using gradient elution using the mobile phase-A consists of a mixture of water-acetonitrile-formic acid (715 : 285 : 1, v/v/v) and the mobile phase-B consists a mixture of methanol-water-formic acid (800 : 200 : 1, v/v/v), respectively.
The developed method is validated for parameters like precision, accuracy, linearity, LOD, LOQ, and ruggedness.
Central composite experimental design (CCD) was applied to check the robustness of the method.
The stability tests were also performed on drug substances as per ICH norms.
American Psychological Association (APA)
Srinivasulu, Kasa& Naidu, Mopidevi Narasimha& Rajasekhar, Kadaboina& Veerender, Murki& Suryanarayana, Mulukutla Venkata. 2012. Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib. Chromatography Research International،Vol. 2012, no. 2012, pp.1-13.
https://search.emarefa.net/detail/BIM-499151
Modern Language Association (MLA)
Srinivasulu, Kasa…[et al.]. Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib. Chromatography Research International No. 2012 (2012), pp.1-13.
https://search.emarefa.net/detail/BIM-499151
American Medical Association (AMA)
Srinivasulu, Kasa& Naidu, Mopidevi Narasimha& Rajasekhar, Kadaboina& Veerender, Murki& Suryanarayana, Mulukutla Venkata. Development and Validation of a Stability Indicating LC Method for the Assay and Related Substances Determination of a Proteasome Inhibitor Bortezomib. Chromatography Research International. 2012. Vol. 2012, no. 2012, pp.1-13.
https://search.emarefa.net/detail/BIM-499151
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-499151