DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF CARBAMAZEPINE IN RAT PLASMA
Validation of bioanalytical procedure is a regulatory requirement. Selective and sensitive analytical methods for the quantitative evaluation of drugs (analytes) are critical for the successful conduct of preclinical studies and as a support to formulation development. During the course of a typical product development program, a defined bioanalytical method undergoes many modifications. In the present study, to cater the need of employment of bioanalytical method for carbamazepine using rat plasma was developed and validated. Present bioanalytical method validation included all of the procedures that demonstrated that, this method used for quantitative measurement of carbamazepine in rat plasma is reliable and reproducible for the intended use. The fundamental parameters assessed for this validation were accuracy, precision, selectivity, sensitivity and reproducibility.