DEVELOPMENT AND VALIDATION OF LC MS/MS METHOD FOR THE ESTIMATION OF ROSIGLITAZONE ENANTIOMERS IN PHARMACEUTICAL FORMULATION

Abstract

A simple, fast, specific and precise LC MS/MS method was developed and validated for determination of rosiglitazone enantiomers in pharmaceutical formulation. The interface used was Atmospheric Pressure Chemical Ionisation Technique. Analysis was performed using a ACI cellu 1 column (150 x 4.6 mm I.D., particle size 5 $\mu$) by isocratic elution with 0.025% formic acid (pH 6): Acetonitrile (15:85) and flow rate was 0.5 ml/min. The calibration plot was linear over the range of 30   70 ng/ml of R Rosiglitazone and 90  210 ng/ml of S Rosiglitazone with a correlation of 0.998 for R and S Rosiglitazone. The method was also validated for the precision and recovery. This optimized mobile phase separated R Rosiglitazone at 3.09 min and S Rosiglitazone at 5.3 min respectively. The proposed LC MS/MS method is suitable for analysis of rosiglitazone enantiomers in pharmaceutical formulations and quality control analysis.