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目的:建立测定复方α-酮酸片中4种酮代氨基酸钙和羟蛋氨酸钙含量的方法。方法:采用离子排斥色谱法,色谱柱为Varian METACARB 87H(300 mm×7.8 mm),流动相为0.012 5 mol·L~(-1)硫酸,流速为0.6 ml·min~(-1),柱温:60℃,检测波长为210 nm。结果:4种酮代氨基酸钙和羟蛋氨酸钙在0.02～0.80 mg·ml~(-1)浓度范围内有良好的线性关系(r>0.999 5),平均加样回收率为98.46%～99.98%,RSD小于1.5%。结论:本方法简便,快速,准确,重复性好,可用于该制剂的质量控制。
OBJECTIVE: To establish a method for the determination of calcium keto-hydroxy-methionine and calcium-hydroxy-methionine in compound a-ketoacid tablets. Methods: Ion exchange chromatography was used. The column was Varian METACARB 87H (300 mm × 7.8 mm), the mobile phase was 0.012 5 mol·L -1 sulfuric acid, the flow rate was 0.6 ml · min -1, Temperature: 60 ℃, detection wavelength of 210 nm. Results: There was a good linearity (r> 0.999 5) between the four calcium keto-amino acids and calcium hydroxy-methionate in the concentration range of 0.02-0.80 mg · ml -1. The average recoveries were 98.46% -99.98% , RSD less than 1.5%. Conclusion: The method is simple, rapid, accurate, reproducible and can be used for the quality control of the preparation.