Method Development and Validation for Quantitative Estimation of Bortezomib in its Bulk and Pharmaceutical Formulation

A new method was established for estimation of Bortezomib by RP-HPLC method. The chromatographic conditions were successfully developed the separation using Phenomenex Luna C18 column 250x4.6mm 5µm, flow rate 1.0 ml/min, mobile phase ratio Acetonitrile : 0.1% formic acid (50: 50 v/v),detection wavelength 280 nm. retention time found to be 5.3 mins. % purity 100.443% respectively. system suitability parameters such as theoretical plates and tailing factor more than 2000 less 2 respectively, resolution 2. analytical validated according ICH guidelines (ICH, Q2 (R1). linearity study in concentration range 20µg-120µg/ml correlation coefficient (r2) 0.9994, recovery 101.37%, RSD repeatability 1.778, intermediate precision 1.537 precise, robust, repeatable. LOD value 2.6402, LOQ 7.281 Hence suggested can used routine analysis API pharmaceutical dosage form.
 Keywords: Analytical Validation, Bortezomib, Phamarmaceutical, formulation.