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

Abstract

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