DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR NIACIN AND ROSUVASTATIN CALCIUM IN SYNTHETIC MIXTURE.
Dhamdhere Rupali Balasaheb*, Chore Jyoti Baburao and Ransing Neelam Gitaram
A simple, precise and rapid HPLC method has been developed and validated for the Estimation of Rosuvastatin
Calcium and Niacin simultaneously in Formulation. Chromatographic Separation of the two drugs was performed
on an Eclips XDB C8 column (150mm×4.6 mmid, 5μm particle size).The mobile phase used was a mixture of
0.2% v/v Aq.acetic acid: methanol: acetonitrile (50:25:25% v/v).Detection was performed at 248 nm and sharp
peaks were obtained Rosuvastatin calcium and Niacin at retention times of 3.43 min and 2.08 min respectively. The
calibration curve was linear in the concentration range 248-752μg/ml for niacin 5.20-15.20μg/ml for Rosuvastatin
calcium; the correlation coefficients were 0.990 and 0.998, respectively. The optimized method showed good
performance in terms of specificity, linearity, detection and quantitation limits, precision and accuracy in
accordance with the International Conference on Harmonization (ICH) Q2 (R1) guidelines.This assay was
demonstrated to be applicable for routine quantitation of Rosuvastatin calcium and niacin in Formulation.
Keywords: HPLC, Niacin, Rosuvastatin Calcium, Validation.
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