Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate : An Endothelin Receptor Antagonist
Joint Authors
Bembalkar, Saroj R.
Jadhav, Sonali L.
Landge, Shashikant B.
Jadhav, Sanjay A.
Niphade, Navanath C.
Mathad, Vijayavitthal T.
Source
Chromatography Research International
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-9, 9 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-10-04
Country of Publication
Egypt
No. of Pages
9
Main Subjects
Abstract EN
Described is a simple, rapid, selective, and stability-indicating RP-LC method for the determination of process and degradation-related impurities of bosentan monohydrate.
Chromatographic separation was achieved on Zorbax SB-Phenyl column thermostated at 35°C under gradient elution by a binary mixture of solvent A (60% phosphate buffer, pH 2.5, and 40% methanol) and solvent B (acetonitrile) at a flow rate of 1.0 mL/min.
Forced degradation was carried out under acidic, alkaline, oxidative, photolytic, and thermal conditions.
Significant degradation is observed in acid and alkali stress conditions.
Process- and degradation-related impurities were characterized by mass spectrometry, 1H NMR, and FT-IR spectral data.
Validation of the developed method was carried out as per ICH requirements.
Regression analysis shows an “r” value (correlation coefficient) of greater than 0.999 for bosentan and five potential impurities.
This method was capable to detect the five impurities at 0.01% of the test concentration of 1.0 mg mL-1.
American Psychological Association (APA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Jadhav, Sonali L.& Niphade, Navanath C.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. 2011. Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate : An Endothelin Receptor Antagonist. Chromatography Research International،Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-509026
Modern Language Association (MLA)
Jadhav, Sanjay A.…[et al.]. Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate : An Endothelin Receptor Antagonist. Chromatography Research International No. 2011 (2011), pp.1-9.
https://search.emarefa.net/detail/BIM-509026
American Medical Association (AMA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Jadhav, Sonali L.& Niphade, Navanath C.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. Stability-Indicating Gradient RP-LC Method for the Determination of Process and Degradation Impurities in Bosentan Monohydrate : An Endothelin Receptor Antagonist. Chromatography Research International. 2011. Vol. 2011, no. 2011, pp.1-9.
https://search.emarefa.net/detail/BIM-509026
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-509026