VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF ROSUVASTATIN CALCIUM IN BULK AND TABLET DOSAGE FORM

Sahana R.*, Sowmya H. G., Jose Gnana Babu C.

ABSTRACT

Simple, precise and accurate zero order derivative spectroscopic method has been developed and validated for the estimation of Rosuvastatin calcium in bulk and Pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 242nm in Acetonitrile solution and obeys Beer’s law in the concentration range of 3-18μg/ml. The linearity study was carried out and regression coefficient was found to be 0.9999=b and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.54-100.55. The LOD and LOQ were found to be 0.076 and 0.23μg/ml. The % relative standard deviation were found to be less than 2. According to ICH guidelines the technique has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine quantification of Rosuvastatin Calcium in bulk and pharmaceutical dosage form.

Keywords: Rosuvastatin Calcium, Zero order derivative spectroscopy, validation, pharmaceutical formulations.