高效液相色谱法分离测定硫酸卷曲霉素的4个组分

目的: 建立1种分离硫酸卷曲霉素4个组分的高效液相色谱法,并定量分析检测了各组分。 方法: 采用Venusil ASB C₁₈ 柱(250 mm× 4.6 mm,5 μm),柱温25℃,流动相为磷酸盐缓冲液(称取磷酸二氢钾54.4 g,加水至1.5 L,溶解,用磷酸调pH至2.5,加入己烷磺酸钠9.4 g,用水稀释至2.0 L)-甲醇-乙腈(84: 8: 8),检测波长:268 nm,流速:0.9 mL·min^-1,进样量:20 μL。 结果: 建立的HPLC法能基线分离硫酸卷曲霉素的4个组分,并能有效分离原料及制剂中的杂质。 结论: 本方法能更好地控制硫酸卷曲霉素原料和制剂的质量。

Objective: To develop an HPLC method and use it to analyze the four components of capreomycin sulfate quantitatively. Methods: A Venusil ASB C₁₈ column(250 mm×4.6 mm,5 μm)was used. The column temperature was 25℃. The mobile phase was phosphate solution (monopotassium phosphate (54.4 g) was dissolved in 1.5 L of water. Then, phosphoric acid was added to adjust the pH to 2.5. After that, 9.4 g of sodium hexanesulfonate was added. The solution was diluted with water to 2.0 L)-methanol-acetonitrile (84: 8: 8). The detection wavelength was set at 268 nm. The velocity was 0.9 mL·min^-1. The sample amount was 20 μL. Results: The baseline separation of the four components of capreomycin sulfate by HPLC was achieved. The impurities in capreomycin sulfate (raw materials) and its preparations were isolated. Conclusion: The HPLC method is useful in quality control of capreomycin sulfate (raw materials) and its preparations.