Development and Validation of Stability Indicating LC-PDA Method for Mycophenolate Mofetil in Presence of Mycophenolic Acid and Its Application for Degradation Kinetics and pH Profile Study
Joint Authors
Nikalje, Anna Pratima G.
Choudhari, Vishnu P.
Source
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-06-30
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Factorial design tool applied for development of isocratic reversed-phase stability-indicating HPLC method for the analysis of mycophenolate mofetil (MMF) and its degradation products.
MMF stress degradation products mycophenolate acid (MPA) and DP3 (USP impurity H) were isolated and used for quantitation.
Separation achieved on a Symmetry C18 (250 mm × 4.6 mm, 5.0 μ) column using a methanol: acetate buffer (75 : 25 v/v), pH 6.0 (adjusted with acetic acid), at 0.5 mL flow rate, column maintained at 55°C, and data integrated at 251 nm.
MMF is subjected to hydrolysis, oxidation, heat degradation, and so forth; under all these conditions degraded products are well separated.
The method validation characteristics included accuracy, precision, linearity, range, specificity, and sensitivity.
Robustness testing is conducted to evaluate the effect of minor changes to the chromatographic conditions and to establish appropriate system suitability parameters.
The proposed method is used to investigate kinetics of acid, alkali hydrolysis and oxidation process.
Major degradation products MPA and DP3 were isolated and quantitated.
Characterization of MPA by NMR and LC-MS/MS and other degraded products by LC-MS/MS is attempted successfully.
The method is used successfully for the quality assessment of three MMF drug commercial formations and its acid, alkali, and oxidative degradation kinetics study.
American Psychological Association (APA)
Choudhari, Vishnu P.& Nikalje, Anna Pratima G.. 2014. Development and Validation of Stability Indicating LC-PDA Method for Mycophenolate Mofetil in Presence of Mycophenolic Acid and Its Application for Degradation Kinetics and pH Profile Study. Advances in Chemistry،Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-493160
Modern Language Association (MLA)
Choudhari, Vishnu P.& Nikalje, Anna Pratima G.. Development and Validation of Stability Indicating LC-PDA Method for Mycophenolate Mofetil in Presence of Mycophenolic Acid and Its Application for Degradation Kinetics and pH Profile Study. Advances in Chemistry No. 2014 (2014), pp.1-9.
https://search.emarefa.net/detail/BIM-493160
American Medical Association (AMA)
Choudhari, Vishnu P.& Nikalje, Anna Pratima G.. Development and Validation of Stability Indicating LC-PDA Method for Mycophenolate Mofetil in Presence of Mycophenolic Acid and Its Application for Degradation Kinetics and pH Profile Study. Advances in Chemistry. 2014. Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-493160
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-493160