DEGRADATION KINETICS OF CARVEDILOL PHARMACEUTICAL DOSAGE FORMS (TABLETS) THROUGH STRESS DEGRADATION STUDY
Keywords:Carvedilol tablets, Impurities profiling, Forced degradation study, Stress study
Objective: The aim of the research work to monitor impurities profiling and degradation kinetics of Carvedilol Pharmaceutical Dosage Form (Tablets) through stress degradation study.
Methods: To study impurity profiling and degradation kinetics Chromatographic condition used as, Inertsil ODS 3V column (150 mm x 4.6 mm, 5μm) with mobile phase consisting Mobile phase-A (Water, Acetonitrile and Trifluroacetic acid in the ratio of 80:20:0.1 v/v/v respectively and pH adjusted to 2.0 with dilute potassium hydroxide solution) and Mobile phase-B (Water and acetonitrile in the ratio of 100:900 v/v respectively) delivered at flow rate of 1.0 ml min-1 and the detection wavelength 240 nm. The column compartment temperature maintained at 40 °C.
Results: Stress degradation study conducted using Acid, Alkali, Oxidation, Humidity, Thermal and Photolytic stress degradation conditions. Known, unknown and degradant impurities nature and degradation kinetics in different stressed degradation conditions were monitored through stability indicated method reverse phase HPLC method. Carvedilol molecule found sensitive to Oxidation and Alkali conditions. Impurity-A significantly increased from its not detected level.
Carvedilol molecule found stable in Acid, Humidity, Thermal and Photolytic stress degradation condition. In all stressed conditions, mass balance was found between 95% to 105% and peak purity of carvedilol peak was found pure.
Conclusion: Stress degradation study is required to know the degradation pathway of product and to prove the stability indicating nature of the analytical method. Study provide information pertaining to the intrinsic stability of drug product.
FDA Approved Drug Products: Carvedilol Oral Tablets. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020297s038lbl.pdf. [Last accessed on 25 Aug 2021]
FDA Approved Drug Products: Carvedilol Oral Extended-Release Capsules. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022012s022lbl.pdf. [Last accessed on 25 Aug 2021]
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