| Acceptance rate | 46% |
|---|---|
| Time to first decision | 6 months* |
| Time to decision with review | 50 days* |
*Approximate number of days
**The days mentioned above are averages and do not indicate exact durations. The process may vary for each article.
ACTA Pharmaceutica Sciencia
2010 , Vol 52 , Num 4
VALIDATED SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF SUNITINIB MALATE, DYE COMPLEXATION APPROACH FOR A NOVEL ANTICANCER DRUG
University of Ege, Faculty of Pharmacy, Department of Pharmaceutical Technology, 35100 Bornova, Izmir, Turkey
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A rapid, selective, sensitive and simple spectrofluorimetric method was developed for the indirect determination of sunitinib malate (SM) in bulk and pharmaceutical preparations. Dye complexation based spectrofluorimetric quantification of SM was performed by the monitorization of emission of the free dye (Eosin Y) at 800 nm following the excitation at 350 nm. Described method was fully validated with the analytical parameters studied being; accuracy, linearity, specificity, limit of detection (LOD), limit of quantification (LOQ), precision, reproducibility and robustness. The described method displayed linearity over the studied 0.08 to 5.00 μg/mL concentration range. 0.041 μg/mL (7.69x10-8 M) and 0.850 μg/mL (1.59x10-6 M) were the LOD and LOQ values, respectively. Defined parameters of the method (such as medium pH, dissolved oxygen concentration, temperature, dye concentration, incubation time and etc.) were changed systematically to check robustness and the method yielded pretty good results. Reproducibility was tested by applying the proposed method to the assay of SM using the same operational conditions, in two different laboratories at different elapsed time by using different instruments. Results obtained from lab-to-lab variations were found to be reproducible, as RSD values did not exceed 2%.
Keywords :
SUNITINIB MALATE, EOSIN Y, ION-PAIR COMPLEX, SPECTROFLUORIMETRIC DETERMINATION, ANALYTICAL METHOD VALIDATION