Abstract
A novel, simple and economic high performance liquid chromatography (HPLC) method has been developed for the estimation of Clofarabine in bulk and tablet dosage form with greater precision and accuracy.The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Clofarabine in bulk and tablet dosage forms. All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.
Highlights
For many years, the Southern Research Institute has had a programme, supported by the US National Cancer Institute, searching for new nucleoside anticancer drugs
Moderate to excellent sensitivity to tumour growth delays were seen in all eight human colon tumours, three out of four human renal tumours, all four non-small-cell lung tumours, and all three prostate tumours
The anticancer activity of clofarabine was dose- and schedule-dependent, and greater antitumour activity was associated with more frequent administration [4].Clofarabine is a second generation purine nucleoside analog with antineoplastic activity
Summary
In the early 1980s, two adenine-containing nucleosides, known as fludarabine (Fludara; Berlex Oncology) and cladribine (Leustatin; Ortho Biotech) were in clinical trials At the time, it was not clear whether either drug would gain approval by the FDA because some concerns were raised during preclinical and clinical development of these agents. Moderate to excellent sensitivity to tumour growth delays were seen in all eight human colon tumours, three out of four human renal tumours, all four non-small-cell lung tumours, and all three prostate tumours. This spectrum of widespread anticancer activity has been confirmed by other investigators in human tumourxenograft models in mice [3]. Clofarabine is phosphorylated intracellularly to the cytotoxic active 5'-triphosphate metabolite, which inhibits the enzymatic activities of ribonucleotide reductase and DNA polymerase, resulting in inhibition of DNA repair and synthesis of DNA and RNA [5,6,7]
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