Novel Method development and Validation of Bortezomib in Bulk and Pharmaceutical dosage form by RP- HPLC
A simple, rapid, precise and accurate RP-HPLC method was developed and validated for the determination of Bortezomib, in bulk and pharmaceutical dosage form. The separation is achieved on RP-HPLC using a PDA detector by incorporation of enpower 2 software with a flow rate of 1.0ml/min using a mixture of Methanol and water (15:85% v/v) as mobile phase. The column used was Hypersil C18 (4.6×150mm, 5µ) at a wave length of 284nm. The retention time of the Bortezomib was 3.515min.. The linearity of the drug was 25-125µg/m and the method precision for the determination of assay was below 2.0% RSD. The proposed method was validated and applied for the estimation of Bortezomib in quality control of bulk and pharmaceutical dosage forms.
Keywords: Bortezomib, RP-HPLC, validation.
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