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ABSTRACT
| Title |
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SOLID DOSAGE FORM OF ANTINEOPLASTIC DRUG IMATINIB MESILATE BY RP HPLC. |
| Authors |
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G. Sathwik, Sonal Dubey, P. Prabitha, D. R. Harish Kumar |
| Keywords |
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RP-HPLC, Validation, Imatinib mesylate, Acetonitrile |
| Issue Date |
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April 2015 |
| Abstract |
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A simple and sensitive High Performance Liquid Chromatographic method has been established and validated for Imatinib Mesylate in pharmaceutical dosage form, separation was performed on a C18, 150×4.6 mm, 5µ column in isocratic mode, with mobile phase containing a mixture of buffer: acetonitrile (72:28 v/v). The mobile phase was pumped at a flow rate of 1.0 ml/min and eluents were monitored at 265 nm. Linearity was found to be in the range of levels 80% to 120% and retention time was 3.63 min. The statistical validation parameters such as linearity, accuracy, precision, and specificity, limit of detection, limit of quantification were checked. The samples were prepared in water and the stability of Imatinib mesylate in aqueous solution at 30°C was studied. The results were satisfactory with good stability after 24 h at 30°C. The proposed method can be used for the related substances of Imatinib mesylate. |
| Page(s) |
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697-705 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 6, No.4 |
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