ABSTRACT

Cancer is a condition in which the unwanted cells spilt up excessively and penetrate neighboring tissues. By the blood and lymph system cancer cells can transmit to other parts of the body. If left untreated cancer may leads to death. If diagnosed early and treated it is curable. Trabectedin is an anticancer agent used for the treatment of cancer. This review focuses on Trabectedin as an anticancer agent and the recently developed analytical techniques in Trabectedin. In this review the analytical techniques in Trabectedin include RP-HPLC, LC-MS method. In RP-HPLC method was developed according to ICH guidelines, for quantifying Trabectedin drug substance and the method is validated. The drugs were injected into a Zorbax SB, C18 (150x4.6mm); 3.5m column kept at room temperature, and the effluent was measured at 215nm. The mobile phase was composed of phosphate buffer (pH 3.0) and acetonitrile in a 70:30 V/V ratio. The flow rate was kept constant at 0.8 ml/min. Trabectedin's calibration curve was linear from 50 to 175 g/ml (r2 for Trabectedin = 1). For the determination of Trabectedin in bulk and pharmaceutical dosage forms, the proposed method was adequate, sensitive, reproducible, accurate, and precise.In LC-MS method was validated in accordance with US Food and Drug Administration guidelines. Linearity, LLOQ, intra- and inter-day accuracy and precision, recovery, matrix effect, selectivity, and stability were among the parameters studied. Keywords: Trabectedin, RP-HPLC, Anticancer, LC-MS, Validation
Publication date: 01/12/2022

https://ijbpas.com/pdf/2022/December/MS_IJBPAS_2022_6509.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.12.6509