Introduction: A simple and reliable high performance liquid chromatographic method has been developed for the quantitative determination of pregabalin in bulk and dosage form. Pregabalin, a γ amino butyric acid analogue, has negligible sensitivity to UV or fluorescence detection. Hence, it has been derivatized by ninhydrin to form a chromophoric complex that could be quantified by UV detection.

Materials and Methods: The concentration of ninhydrin was set to 5 mg/ml and a phosphate buffer solution (pH 7.4) was used as a solvent for the reaction. The resultant complex was separated by HPLC and detected by a UV detector at 569nm wavelength.

Results: The developed method showed a linear response within 50 to 600 μg/mL of pregabalin. The method was accurate with mean recovery values within 100 ± 2%. The repeatability of the method was established by intra-day and inter-day precision study. Finally, a commercial pregabalin capsule was assayed by the developed HPLC method including ninhydrin derivatization. The result of the mean assay was found to be 100.37 ±2.94 %.

Conclusion: This is the first time we are reporting pregabalin analysis using ninhydrin derivatization for HPLC analysis. Therefore, the developed method can be considered as a significant improvement in pregabalin quantitation and it can be easily applied for routine quality control tests of pregabalin.

简介：已经开发了一种简单可靠的高效液相色谱方法，用于定量测定散装和剂型中的普瑞巴林。普瑞巴林是一种γ氨基丁酸类似物，对紫外线或荧光检测的敏感性可以忽略不计。因此，它已经被茚三酮衍生化以形成发色复合物，该复合物可通过紫外检测定量。

材料和方法：茚三酮的浓度设置为5 mg / ml，磷酸盐缓冲溶液（pH 7.4）用作反应的溶剂。通过HPLC分离所得复合物，并通过UV检测器在569nm波长下检测。

结果：所开发的方法显示普瑞巴林的线性响应在50至600μg/ mL之间。该方法准确，平均回收率在100±2％之内。通过日内和日间精度研究确定了该方法的可重复性。最后，通过开发的HPLC方法（包括茚三酮衍生化）来测定市售普瑞巴林胶囊。发现平均测定的结果为100.37±2.94％。

结论：这是我们首次报告使用茚三酮衍生化进行普瑞巴林分析的HPLC分析。因此，所开发的方法可以认为是普瑞巴林定量的显着改进，并且可以轻松地用于普瑞巴林的常规质量控制测试中。