Stability indicating ultraviolet spectroscopic method for the estimation of ezetimibe and carvedilol.
In this study, new and rapid stability indicating ultraviolet spectroscopic methods were developed and validated for the estimation of ezetimibe and carvedilol in pure form and in their respective formulations. Since both the drugs are poorly water soluble, 20% v/v acetonitrile in triple distilled water was selected as the solvent system for both the drugs. This ensured adequate drug solubility and maximum assay sensitivity. The linearity range for ezetimibe and carvedilol at their respective wavelength of detection of 232 nm and 238 nm was obtained as 2-50 microg/ml and 2-20 microg/ml respectively. The linear regression equations obtained by least square regression method, were Y = 0.0443 x (X) + 0.0106 for ezetimibe and Y = 0.1080 x (X) + 0.034 for carvedilol, where Y is the absorbance and X is the concentration (in microg/ml) of pure drug solution. The detection and quantitation limit as per the error propagation theory were found to be 0.4 microg/ml and 1.3 microg/ml respectively for ezetimibe and 0.7 microg/ml and 2.1 microg/ml respectively for carvedilol. The methods were employed with high degree of precision and accuracy for the estimation of total drug content in two commercial tablet formulations of each of the two drugs. It was concluded that both the developed methods are accurate, sensitive, precise, and reproducible. They can be applied directly for the estimation of drug content in pharmaceutical formulations.
Imran
M
M
Formulation Development & Pharmacokinetic Laboratory, Pharmacy Group, Birla Institute of Technology & Science, Pilani, India.
Singh
R S P
RS
Chandran
S
S
D000319:Adrenergic beta-Antagonists / Q000032:analysis*; D001384:Azetidines / Q000032:analysis*; D002138:Calibration; D002227:Carbazoles / Q000032:analysis*; D000077261:Carvedilol; D004355:Drug Stability; D000069438:Ezetimibe; D000960:Hypolipidemic Agents / Q000032:analysis*; D011412:Propanolamines / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents; D013056:Spectrophotometry, Ultraviolet; D019265:Spectroscopy, Near-Infrared
D000319:Adrenergic beta-Antagonists; D001384:Azetidines; D002227:Carbazoles; D000960:Hypolipidemic Agents; D011412:Propanolamines; D012997:Solvents; D000077261:Carvedilol; D000069438:Ezetimibe