DEVELOPMENT OF AN HPLC METHOD WITH UV DETECTION FOR THE PHARMACEUTICAL QUALITY CONTROL OF THE NOVEL MARINE ANTICANCER AGENT KAHALALIDE F

Autor: M. Bouma, Auke Bult, Pablo Floriano, E. Stokvis, Bastiaan Nuijen, Hilde Rosing, Manada C, Jos H. Beijnen, J. J. Kettenes-van den Bosch
Rok vydání: 2001
Předmět:
Zdroj: Journal of Liquid Chromatography & Related Technologies. 24:3141-3155
ISSN: 1520-572X
1082-6076
DOI: 10.1081/jlc-100107725
Popis: Kahalalide F is a cyclic depsipeptide derived from the marine mollusc Elysia rufescens, an organism living in the seas near Hawaii. On the basis of its in vitro and in vivo selectivity, kahalalide F is currently developed as a potential anticancer agent against androgen independent prostate tumors. The development and validation of a reversed-phase high performance liquid chromatography (RP-HPLC) method with ultra-violet (UV) detection for the quantification and purity determination of kahalalide F in raw drug substance and pharmaceutical dosage form is described. Linear calibration curves in the range of 0.5–12.5 μg/mL of kahalalide F with correlation coefficients > 0.999 were obtained. Within-run and between-run precisions were ≤ 3.0% and accuracy was within 100.4–103.2%. The assay proved selective, as determined by stress-testing, confirming its stability indicating capacity. Using liquid chromatography-mass spectrometry (LC-MS) analysis, kahalalide G, the hydrolyzed open-chain analog of kahalalide F, ...
Databáze: OpenAIRE
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