ABSTRACT:
The determination of Carvedilol in bulk as well as in formulations was done in this study by brining upon a new approach and validating it to be a sensitive, accurate and simple analytical method. The analytical approach was done using a UV spectrophotometer with the application of multivariate calibration. The relationship between concentration and absorbance taken at five different wavelengths including the absorption maxima has been used to develop this multivariate calibration technique. The linear regression equations, residual sum of squares and other mathematical as well as statistical approaches were used for the validation of process according to ICH Q2 (R1) guidelines. The validation parameters that need to be accomplished were precision, accuracy, linearity, and others as mentioned in the guidelines. There was linearity in the plot between the concentration and absorbance in the concentration level of 3 -5µg/mL with a good correlation coefficient of R2 = 0.9989. The linear regression equation calculated was: y = 0.1167x + 0.01944. The detection limit and the quantitation limit as calculated were 0.036µg/mL and 0.109 µg/mL respectively. This method has good sensitivity with satisfactory results and can be implemented in routine analysis of bulk drugs and formulations at low cost.