A rapid, precise, specific, accurate and simple UV spectrophotometric method was developed and validated for the estimation of Rosuvastatin calcium and clopidogrel bisulphate in combined pharmaceutical dosage forms and laboratory prepared mixtures. The method was validated in terms of linearity, accuracy, precision, and specificity, limit of detection (LOD) and limit of Quantitation (LOQ) as per ICH guideline. To overcome the problem of spectral interference first order derivative spectroscopic method were adopted. The method obeys Beer’s Law in concentration ranges of 2-10 µg/ml for both drug. The λmax of Rosuvastatin calcium and Clopidogrel bisulphate were found to be at 244 nm and 219 nm respectively. The linearity ranges of both drugs were found to be in the range of 2- 10 μg/ml. The selected wavelengths by first order derivative method were found to be 323 nm for Rosuvastatin calcium and 243 nm for Clopidogrel bisulphate. The LOD and LOQ value were found to be 0.420 µg/ml and 0.874 µg/ml for Rosuvastatin calcium and 0.120 µg/ml and 0.365 µg/ml for Clopidogrel bisulphate respectively. The optimum conditions for the analysis of the drug were established. The percentage recovery of Rosuvastatin calcium and Clopidogrel bisulphate were 97-99.40 and 99.6-101.36 respectively. The developed method was successfully applied to the laboratory prepared mixtures.
Loading....