高效液相色谱法测定醋酸来法莫林的有关物质

摘要：目的 建立高效液相色谱法测定醋酸来法莫林的有关物质。方法 采用C18色谱柱(25 cm×4.6 mm，5 μm)，流动相A：60 mmol/L磷酸二氢钾溶液(磷酸调pH至2.5)-乙腈(80:20，V/V)，流动相B：60 mmol/L磷酸二氢钾溶液(磷酸调pH至2.5)-乙腈(50:50，V/V)，梯度洗脱；流速1 mL/min；检测波长210 nm；柱温30℃；进样体积20 μL。结果 醋酸来法莫林与各有关物质分离良好；醋酸来法莫林在0.50~75.33 μg/mL的浓度范围内，浓度与峰面积呈良好的线性关系，相关系数为1.000，醋酸来法莫林的检测限为0.20 μg/mL。结论 该方法专属、可靠，可用于醋酸来法莫林有关物质的测定。

Determination of related substances in lefamulin acetate by HPLC

Abstract Objective To establish a high performance liquid chromatography method for the determination ofrelated substances in lefamulin acetate. Methods A C18 column (25 cm×4.6 mm, 5 μm) was used with mobile phase A:60 mmol/L potassium dihydrogen phosphate solution (pH adjusted to 2.5 with phosphoric acid)-acetonitrile (80:20, V/V), mobile phase B: 60 mmol/L potassium dihydrogen phosphate solution (pH adjusted to 2.5 with phosphoric acid)-acetonitrile (50:50, V/V), gradient elution, flow rate at 1 mL/min, detection wavelength at 210 nm, column temperatureat 30℃, and injection volume of 20 μL. Results Lefamulin acetate was well separated from the related substances.Lefamulin acetate was within the concentration range of 0.50~75.33 μg/mL, and the concentration and peak area showeda good linear relationship. The correlation coefficient was 1.000. The limit of detection is 0.20 μg/mL. Conclusion Thismethod is exclusive and reliable, and can be used for the determination of related substances in lefamulin