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

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 μ) 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.