Validated Reverse Phase High Performance Liquid Chromatography Technique for Quality Analysis of Rosuvastatin Calcium Molecule in Tablet Dosage Form

Abstract

Introduction
A simple, reliable, precise reverse phase high performance liquid chromatography (RP-HPLC) method  has been developed and validated for the estimation of rosuvastatin calcium in tablet dosage form.

Methods
RP-HPLC separation was achieved on an C18, 5µm particle size (150mm x 4.6mm ID) column using a mobile phase of  KH₂PO₄ and methanol  (70:30) at a flow rate of 0.75ml/min at temperature of 40⁰C, run time 10 min detected at 242 nm using UV detector. The method was validated for system suitability, linearity, accuracy, precision and 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 was 1.07 which shows the method is precise. The accuracy minimum recovery value was 98.5 % and maximum recovery value was 101.97 %.

Conclusions
The developed method is basic, fast, precise and reproducible and thus can be used for the routine quality analysis of rosuvastatin calcium.