Spectroscopic substantiation for the identification of degradants by Q-TOF micromass (ESI-MS) in bisoprolol fumarate with an inventive validation approach for stability indicating HPLC method
By: Pandey, Swati
.
Contributor(s): Pandey, Ravindra.
Publisher: Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022Edition: Vol.56(1), Jan-Mar.Description: 272-280p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical education and researchSummary: Background: Stability studies, stress testing of drug substances and finished drug
product is obligatory due to the guidelines by the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other
Regulatory Authorities. Materials and Methods: In the present work the selective Beta-1
receptor blocker, Bisoprolol fumarate was subjected to the forced degradation studies
which includes hydrolysis (acidic, basic and neutral), oxidative, photolytic and thermal
degradation. The drug was stable under light and basic and neutral medium. Results: The
major findings in the presented work are the degradation products formed in the course
of thermal degradation. The complete thermal degradation products were identified
by High Performance Liquid Chromatography, Quadrupole-Time of Flight micromass
(Electronspray Ionization-Mass Spectroscopy). The chromatographic conditions opted for
the study includes Cosmosil C -18 column (4.6ID*250mm) with mobile phase consisting
of methanol: phosphate buffer (pH 3.5 adjusted with orthophosphoric acid): Acetonitrile
(45:35:20). Conclusion: The stability indicating method was validated as per the
International Conference on Harmonization guidelines. The use of superior statistical
tools for validation ensures the efficiency, quality and reproducibility of the presented
method. Results obtained were agreeable and ensured the quality and reproducibility of
the method.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2022-1726 |
Background: Stability studies, stress testing of drug substances and finished drug
product is obligatory due to the guidelines by the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other
Regulatory Authorities. Materials and Methods: In the present work the selective Beta-1
receptor blocker, Bisoprolol fumarate was subjected to the forced degradation studies
which includes hydrolysis (acidic, basic and neutral), oxidative, photolytic and thermal
degradation. The drug was stable under light and basic and neutral medium. Results: The
major findings in the presented work are the degradation products formed in the course
of thermal degradation. The complete thermal degradation products were identified
by High Performance Liquid Chromatography, Quadrupole-Time of Flight micromass
(Electronspray Ionization-Mass Spectroscopy). The chromatographic conditions opted for
the study includes Cosmosil C -18 column (4.6ID*250mm) with mobile phase consisting
of methanol: phosphate buffer (pH 3.5 adjusted with orthophosphoric acid): Acetonitrile
(45:35:20). Conclusion: The stability indicating method was validated as per the
International Conference on Harmonization guidelines. The use of superior statistical
tools for validation ensures the efficiency, quality and reproducibility of the presented
method. Results obtained were agreeable and ensured the quality and reproducibility of
the method.
Click on an image to view it in the image viewer
There are no comments for this item.