Analytical Method Development and Stability Studies of Carvedilol

Masters Thesis from the year 2011 in the subject Medicine - Pharmacology, Pharmacy, grade: 8.0, course: B.Pharm., M.Pharm, language: English, abstract: A reverse phase high performance liquid chromatographic method (HPLC) has been developed for the method development validation of Carvedilol in bulk and pharmaceutical formulation by using YMC PACK PRO 4.6 X 150 mm (5 m Particle size). The mobile phase was Buffer: Acetonitrile: (70:30) and pH was adjusted to 2 pumped at a flow rate of 1 ml/min and the eluents were monitored at 320nm. Linearity was obtained in the concentration range of 10-90 μg/ml. The retention time of Carvedilol was found to be 3.2 minute. The method was validated for specificity, accuracy, precision, linearity, and limit of detection, limit of quantification, robustness and solubility stability. LOD and LOQ were found to be 0.001 μg/ml and 0.011μg/ml respectively. The method was statistically validated and RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. Stability study report revealed that the drug is susceptible for acidic, alkaline, oxidative, photolytic and UV degradation. The drug is stable to thermal degradation. More over the degradants were well separated from its API. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining Carvedilol in bulk drug samples or in pharmaceutical dosage forms.