Stress Degradation Behavior of Paliperidone, an Antipsychotic Drug, and Development of Suitable Stability-Indicating RP-LC Method
Joint Authors
Bembalkar, Saroj R.
Solanki, Pavankumar V.
Jadhav, Sanjay A.
Landge, Shashikant B.
Choudhari, Pramod M.
Mathad, Vijayavitthal T.
Source
Chromatography Research International
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-06-23
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A new, simple, rapid, and stability-indicating reversed phase liquid chromatographic (RP-LC) method for the determination of both assay and related substances in paliperidone has been developed and validated.
During the forced degradation at hydrolysis, oxidative, photolytic, and thermal stressed conditions, the degradation was observed in the oxidative and acid stress conditions.
Five process-related impurities (Imp-A to Imp-E) in test sample of paliperidone have been detected using newly developed RP-LC method.
Among the five, Imp-C and Imp-D were found to be degrdants.
Good resolution between the peaks corresponding to degradation and process-related impurities from the analyte was achieved on a Hypersil BDS C18 (250×4.6 mm, 5 μm) column.
The stress samples were assayed against a qualified reference standard, and the mass balance was found to be close to 99.0%.
The method was validated as per ICH guideline and was found to be robust.
The proposed RP-LC method was successfully applied to the analysis of commercial formulation and was found to be specific and selective.
American Psychological Association (APA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Choudhari, Pramod M.& Solanki, Pavankumar V.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. 2011. Stress Degradation Behavior of Paliperidone, an Antipsychotic Drug, and Development of Suitable Stability-Indicating RP-LC Method. Chromatography Research International،Vol. 2011, no. 2011, pp.1-10.
https://search.emarefa.net/detail/BIM-457894
Modern Language Association (MLA)
Jadhav, Sanjay A.…[et al.]. Stress Degradation Behavior of Paliperidone, an Antipsychotic Drug, and Development of Suitable Stability-Indicating RP-LC Method. Chromatography Research International No. 2011 (2011), pp.1-10.
https://search.emarefa.net/detail/BIM-457894
American Medical Association (AMA)
Jadhav, Sanjay A.& Landge, Shashikant B.& Choudhari, Pramod M.& Solanki, Pavankumar V.& Bembalkar, Saroj R.& Mathad, Vijayavitthal T.. Stress Degradation Behavior of Paliperidone, an Antipsychotic Drug, and Development of Suitable Stability-Indicating RP-LC Method. Chromatography Research International. 2011. Vol. 2011, no. 2011, pp.1-10.
https://search.emarefa.net/detail/BIM-457894
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-457894