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目的建立利用高效液相色谱法测定胸腺肽-α1含量的探讨分析。方法色谱柱:C18柱(φ4.6×250 mm,Agilent,USA);流动相:A:0.1%三氟乙酸;B:80%乙腈及0.1%三氟乙酸;流速:1.0 ml/min;检测波长:220 nm;柱温:室温;压力:15 MPa;梯度:乙腈浓度20%～40%。进样量为20μl。样品浓度1 mg/ml。高效液相色谱法进行检测。结果以日达仙作为标准品,在同样HPLC色谱条件及相同样品浓度下对国产的迈普新、和日及基泰进行测定,发现国产迈普新、和日及基泰纯度高,与日达仙相同纯度均大于99%。以峰面积进行样品含量计算,基泰含量高于迈普新及和日,国产胸腺肽-α1的效价比远高于日达仙。结论高效液相色谱法测定胸腺肽-α1的纯度及含量重现性好,准确度高,专属性强。
Objective To establish a method for the determination of thymosin-α1 by high performance liquid chromatography. Methods Column: C18 column (4.6 × 250 mm, Agilent, USA); mobile phase: A: 0.1% trifluoroacetic acid; B: 80% acetonitrile and 0.1% trifluoroacetic acid; Wavelength: 220 nm; column temperature: room temperature; pressure: 15 MPa; gradient: acetonitrile concentration 20% ~ 40%. Injection volume of 20μl. Sample concentration 1 mg / ml. High performance liquid chromatography for detection. Results With Radix Asarum as the standard product, the domestic Maipu Xin, Japan and Kettai were tested under the same HPLC chromatographic conditions and the same sample concentration. The results showed that domestic Maipu new, Japanese and Ketai high purity, and Japan Daxian the same purity greater than 99%. The peak area of the sample content calculation, the content is higher than the Thai Kitai Maipu and Japan and Japan, the domestic price of thymosin-α1 is much higher than the potency of Japan than immortality. Conclusion The purity and content of thymosin-α1 determined by high performance liquid chromatography has good reproducibility, high accuracy and specificity.