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目的:对注射用达托霉素有关物质测定方法进行优化。方法:采用IB-SIL C-8(250 mm×4.6 mm,5μm)色谱柱;以0.039 mol·L~(-1)磷酸二氢铵(用1 mol·L~(-1)磷酸溶液调节pH至3.25)-乙腈(80∶20)为流动相A,以0.039 mol·L~(-1)磷酸二氢铵(用1 mol·L~(-1)磷酸溶液调节pH至3.25)-乙腈(50∶50)为流动相B;柱温:20℃;流速:1.5 ml·min~(-1);检测波长:214 nm。结果:注射用达托霉素在0.39~77.25#g·ml~(-1)线性范围内浓度与峰面积呈良好线性关系,r=1.000 0,最低检测限为2.4 ng,达托霉素与已知和未知杂质分离度良好。结论:本法可用于注射用达托霉素的有关物质的测定。
Objective: To optimize the determination of daptomycin-related substances for injection. METHODS: The chromatographic column was packed with IB-SIL C-8 (250 mm × 4.6 mm, 5 μm) and the pH was adjusted with 0.039 mol·L -1 ammonium dihydrogen phosphate To 3.25) -acetonitrile (80:20) was used as mobile phase A, pH was adjusted to 3.25 with 0.039 mol·L -1 ammonium dihydrogen phosphate (1 mol·L -1 phosphoric acid solution) 50:50) as mobile phase B; column temperature: 20 ℃; flow rate: 1.5 ml · min -1; detection wavelength: 214 nm. Results: There was a good linear relationship between the concentration and the area of daptomycin for injection in the linear range of 0.39-77.25 # g · ml -1, r = 1.000 0, the lowest detection limit was 2.4 ng, Known and unknown impurity separation is good. Conclusion: This method can be used for the determination of daptomycin for injection of related substances.