Abstract
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.
Highlights
Carvedilol chemically it is named, (±)-1-(carbazol-4-yloxy)-3-((2-omethoxyphenoxy) ethyl) amino)-2-propanol
Impurities in pharmaceuticals are the unwanted chemical that remain with the active pharmaceutical ingredients (APIs), or develop during formulation or upon aging of the both API and formulated APIs to medicines
Stress degradation studies provide vital information in developing new drug molecule or drug product. It give the necessary information of degradation pathway of the molecule which will play very important role in stability of drug product
Summary
Carvedilol chemically it is named, (±)-1-(carbazol-4-yloxy)-3-((2-omethoxyphenoxy) ethyl) amino)-2-propanol. Carvedilol is a racemic mixture where the S(-) enantiomer is a beta-adrenoceptor blocker and the R (+) enantiomer is both a beta and alpha-1 adrenoceptor blocker and is currently used to treat heart failure, left ventricular dysfunction and hypertension [1, 2]. Carvedilol shows greater antioxidant activity than other commonly used beta-blockers [3, 4]. It has been prescribed as an antihypertensive agent, an antiangina agent [5,6,7,8]. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension [9]. Stress degradation indicates the chemical behaviour of the molecule, which give the necessary information in development of pharmaceutical dose
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