A Sensitive Spectrophotometric Method for the Determination of Pregabalin in Bulk, Pharmaceutical Formulations and in Human Urine Samples

摘要

A simple and sensitive spectrophotometric method was developed and validated for the determination ofpregabalin in bulk, pharmaceutical formulations and in human urine samples. the method was based on thereaction of drug with the mixture of potassium iodate and potassium iodide. the method was linear in therange of 0.5-3.5 μg/ml. There is no official method for the determination of pregabalin. The absorbance wasmeasured at 353 nm. The method was validated with respect to accuracy, precision, specificity, ruggedness,robustness, limit of detection and limit of quantitation. this method was used successfully for the qualityassessment of five pregabalin drug products and in human urine samples with good precision and accuracy.