Objective To establish the determination method of four kinds of amino acid of Compound a -keto Acid Tablets. Methods Reverse phase HPLC was used, O-Phthalaldehyde and 2-Mercaptoethanol were used as the derivative of reagent to determine the content of four amino acids of acetate of compound a-keto acid film lysine, threonine, histidine and tyrosine. The column was Lichrospher C18 25 cm x 4.6 mm; mobile phase was acetonitrile-acetate buffer system gradient elution; detection wavelength was 335 nm. Results The nature of the derivatization product was stability; four kinds of amino acids had the respective concentration linear range (r > 0.999 0); recoveries were 99.8%-101.1%, relative standard deviations were smaller than 2.0%. Conclusion The method is accurate, simple, reproducible, specific, and can be used for the control of the quality of the product.%目的 建立复方α酮酸片中4种氨基酸的含量测定方法.方法 针对复方α酮酸片中赖氨酸醋酸盐、苏氨酸、组氨酸及酪氨酸四种氨基酸,采用反相高效液相法,以邻苯二甲醛(OPA)和2-巯基乙醇为衍生化试剂,测定四种氨基酸的含量.色谱柱为Lichrospher C18 25 cm×4.6 mm;流动相:乙腈-醋酸盐缓冲液系统梯度洗脱；检测波长:335 nm.结果 衍生化产物性质稳定；4种氨基酸在各自的浓度范围内线性关系良好(r＞0.999 0)；加样回收率为99.8％～101.1％,相对标准偏差均小于2.0％.结论 该方法准确,简便,重现性好,专属性强,可用于该产品的质量控制.
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