Validated RP- HPLC Technique for Quality analysis of Rosuvastatin Calcium Molecule in Tablet Dosage Form

Abstract

Introduction:

A simple, reliable, precise reversed phase high performance liquid chromatography (RP- HPLC) method has been developed and validated for the estimation of Rosuvastatin Calcium in pharmaceutical dosage form.

Methods:

RP- HPLC separation was achieved on an C18, 5µmparticle size ( 150mm x 4.6mm ID) column using a mobile phase of  210 ml of 0.02M KH₂PO₄ and 90 ml of Acetonitrile  (70:30) at a flow rate of 0.75ml/min at temperature of 40⁰C, Run time 6min.The detection was carried out at 242nm using UV detector. The method was validated for system suitability, linearity, accuracy, precision, robustness.

Results:

The method was found to be linear in the drug concentration range of 38 – 72 µg/ml with correlation coefficient of 0.9996. The precision (relative standard deviation , RSD) among  9 sample preparation was 1.07. The accuracy minimum recovery value was 98.54 % and maximum recovery value was 101.975 % respectively. The system suitability or repeatability RSD peak area was 0.32962 %.

Conclusions:

Therefore, the developed method is basic, fast, precise and reproducible and thus can be used for the routine quality analysis of Rosuvastatin Calcium molecule.