UV SPECTROPHOTOMETRIC ESTIMATION OF SUNITINIB MALATE IN PHARMACEUTICAL DOSAGE FORM
Objective: To develop and validate simple zero (D0), first (D1) and second (D2) order derivative UV Spectrophotometric methods for the determination of Sunitinib malate in pharmaceutical dosage form.
Methods: Sunitinib malate was solubilised in distilled water and the resultant solution exhibits adsorption maximum (Î»max) at 431, 457 and 489 nm in D0, D1 and D2 order derivative modes respectively. The developed method was validated as per ICH guidelines .
Results: Linearity was obtained over the concentration range of 2-12 Âµg/ml in all the derivative modes. Limit of detection (LOD) was found to be 0.291, 0.107, 0.327Î¼g/ml and Limit of quantification (LOQ) was found to be 0.883, 0.324, 0.993Î¼g/ml for D0, D1 and D2 order derivative modes respectively. The proposed method demonstrated an excellent intra-day precision and inter-day precision. Mean recovery was found within the range of 98.19-98.62% respectively, signifies the accuracy of the developed method.
Conclusion: The statistical results prove that the developed method can be effectively applied for the routine analysis of Sunitinib malate in industries and other analytical laboratories.
2. Edwin P Rock, Vicki goodman, Janet X Jiang, Kooros Mahjoob, S Leigh Verbois, David Morse, et al. Food and drug administration drug approval summary: sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma. Oncologist 2007;12:107-13.
3. Val R Adams, Markos Leggas. Sunitinib malate for the treatment of metastatic renal cell carcinoma and gastrointestinal stromal tumors. Clin Ther 2007;29:1338-53.
4. andhya B, Chinnari Harika V, Bikshal Babu Kasimalla, Reshma Syed, Kalpana Pammi. RP-HPLC method development and validation for the analyisis of Sunitinib in pharmaceutical dosage forms. Int J Sci Innovations Discoveries 2011;1:441-50.
5. De Bruijn P, Sleijfer S, Lam MH, Mathijssen RH, Wiemer EA, Loos WJ. Bioanalytical method for the quantification of Sunitinib and its n-desethyl metabolite SU12662 in human plasma by Ultra performance liquid chromatography/tandem triple quadrupole Mass spectrometry. J Pharm Biomed Anal 2010;51:934-41.
6. Marie Christine Etienne-Grimaldi, Nicole RenÃ©e, Hassan Izzedine, GÃ©rard Milano. A routine feasible HPLC analysis for the anti-angiogenic tyrosine kinase inhibitor, Sunitinib, and its main metabolite, SU12662, in plasma. J Chromatogr 2009;877:3757-61.
7. Benoit Blanchet, Carole Saboureau, Anne-Sophie Benichou, Bertrand Billemont, Fabrice Taieb, Stanislas Ropert, et al. Development and validation of an HPLC-UV-visible method for sunitinib quantification in human plasma. Clin Chim Acta 2009;404:134-9.