ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TRABECTEDIN IN BULK AND PARENTERAL DOSAGE FORM BY RP-HPLC

A new RP-HPLC method for the quantitative determination of Trabectedin was developed and validated as per ICH guidelines. The drugs were injected into Zorbax SB, C18,(150x4.6mm); 3.5µm column maintained at ambient temperature and effluent monitored at 215nm. The mobile phase consisted of phosphate buffer (pH 3.0) and Acetonitrile in the ratio of 70:30 V/V. The flow rate was maintained at 0.8 ml/min. The calibration curve for Trabectedin was linear from 50-175µg/ml (r 2 for Trabectedin = 1 ). The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Trabectedin in bulk and pharmaceutical dosage forms. Keywords: Trabectedin, Linearity , Accuracy, Validation.