Development and Validation of Pregabalin in Bulk,Pharmaceutical Formulations and in Human Urine Samples by UV Spectrophotometry

摘要

A simple and sensitive UV spectrophotometric method was developed and validated for the determination of pregabalin in bulk, pharmaceutical formulations and in human urine samples. The method was linear in the range of 0.5-5.0 μg/ml. There is no generally accepted method for the determination of pregaba-lin. The absorbance was measured at 210 nm. The method was validated with respect to accuracy, precision, specificity, ruggedness, and robustness, limit of detection and limit of quantitation. This method was used successfully for the quality assessment of five pregabalin drug products and in human urine samples with good precision and accuracy. This is found to be simple, specific, precise, accurate, repr-oducible and low cost UV Spectrophotometric method.