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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,5μm),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:20μL。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 establish a high performance liquid chromatography (HPLC) method for the separation of four components of capreomycin sulfate and determine the components by quantitative analysis. Methods: Venusil ASB C18 column (250 mm × 4.6 mm, 5 μm) was used. The column temperature was 25 ℃. The mobile phase consisted of phosphate buffer (weighed 54.4 g of potassium dihydrogen phosphate, dissolved in 1.5 L of water, To 2.5, 9.4 g of sodium hexanesulfonate was added and diluted with water to 2.0 L) of methanol-acetonitrile (84: 8: 8) at a detection wavelength of 268 nm and a flow rate of 0.9 mL.min-1. . Results: The established HPLC method can separate the four components of capreomycin sulfate baseline and effectively separate the impurities in the raw materials and preparations. Conclusion: This method provides better control over the quality of capreomycin sulfate starting materials and preparations.