Gujral Rajinder Singh, Haque Sk Manirul, Shanker Prem
Vardhman Chemtech Ltd, Nimbua, Dera Bassi, Mohali (Punjab) India.
Int J Biomed Sci. 2009 Dec;5(4):421-7.
A simple and sensitive spectrophotometric method was developed and validated for the determination of pregabalin in bulk, pharmaceutical formulations and in human urine samples. The method was based on the reaction of drug with the mixture of potassium iodate and potassium iodide. The method was linear in the range of 0.5-3.5 μg/ml. There is no official method for the determination of pregabalin. The absorbance was measured 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 quality assessment of five pregabalin drug products and in human urine samples with good precision and accuracy.
开发并验证了一种简单灵敏的分光光度法，用于测定原料药、药物制剂和人尿样中的普瑞巴林。该方法基于药物与碘酸钾和碘化钾混合物的反应。该方法在0.5 - 3.5μg/ml范围内呈线性。目前尚无测定普瑞巴林的官方方法。在353nm处测量吸光度。该方法在准确度、精密度、特异性、耐用性、稳健性、检测限和定量限方面进行了验证。该方法已成功用于五种普瑞巴林药品的质量评估以及人尿样分析，具有良好的精密度和准确度。
