Development and Validation of a Complexometric Titration Method for the Determination of Rosuvastatin Calcium in Raw Material

Aims: An easy, sensitive and inexpensive volumetric method for the determination of rosuvastatin calcium in raw material has been developed.

Methodology: The titrimetric method is based on the reaction of calcium with a solution of Disodium ethylene diaminotetraacetate (EDTA) - Magnesium 0.01 M. Hydroxynaphtol blue was used as indicator. It changes from pink to blue at pH = 10 at the end point of the titration. The method was validated for linearity, precision and accuracy, following the suggestions of the International Conference on Harmonization (ICH).

Results: The linearity of the volumetric method was determined by analysis of six replicates at 80%, 100% and 120% and three replicates at 90% and 110% of analyte concentration. The calibration curve was linear, with r = 0.9998. Assay method precision was evaluated by carrying out six independent assays of bulk drug and the intermediate precision was also verified using different analyst and different day in the same laboratory. Accuracy (mean recovery 99.0%) and precision were found to be satisfactory.

Conclusion: The proposed method can be used for quality control assay of rosuvastatin calcium in bulk drug.