| Abstract: | Abstract A validated flow injection spectrophotometric assay has been developed and optimized for the determination of gemfibrozil in pharmaceutical formulations. The method is based on the direct measurement of the absorbance of the analyte—under flow conditions—in basic medium, at 276 nm. The assay was optimized in terms of sample injection volume and flow rate and validated in terms of linearity, repeatability, detection limit, accuracy, and selectivity. Linear calibration curve was obtained in the range of 20–100 mg l?1, while the detection limit (1.4 mg l?1), the repeatability (s r <1.0%, n=12) and the sampling rate (30 h?1) were satisfactory. The method was applied successfully to the quality control of one batch (batch no. 052) and the stability control of three batches (batches no. 049–051) of a gemfibrozil‐containing formulation (Prelisin®, Cosmopharm Ltd, Greece). |
