Validation of HPLC and UV spectrophotometric methods for the determination of bezafibrate in pharmaceutical formulations

摘要

An isocratic high performance liquid chromatographic (HPLC) and a UV spectrophotometric method were developed and validated for the determination of bezafibrate in pharmaceutical formulations. Bezafibrate was performed on a C-18 analytical column (150 x 4.6 mm i.d., 5 mu m) with 0.01 M phosphate buffer (pH 3.5):acetonitrile:methanol (50:40:10) as mobile phase, at a flow rate of 1.0 mL min(-1). For both methods, detection was made at 230 nm. Method validation evaluated parameters such as linearity, precision, accuracy, and specificity, which remained within acceptable limits. Method comparison demonstrated that there is no significant difference between the procedures (p < 0.05).