【摘要】 目的 建立HPLC法测定新型促性腺激素释放激素（GnRH）拮抗剂LPM7100328原料药中的有关物质。方法 采用ACE Excel Super C₁₈（4.6 mm×150 mm,3μm）色谱柱，以0.01mol·L^-1磷酸二氢钾水溶液（用磷酸调节pH值至2.5）为流动相A，乙腈-甲醇（80∶20）为流动相B，梯度洗脱，流速为1.0 mL·min^-1，检测波长为248 nm，柱温为40℃。结果LPM7100328和各杂质峰能够有效分离，在研究浓度范围内与峰面积线性关系良好；LPM7100328及杂质A、B、C的检测限分别为0.0746、0.0714、0.0740、0.0741μg·m L^-1。结论 该方法专属性好，灵敏度高，可准确测定LPM7100328原料药中的有关物质，为LPM7100328的后续研究及质量控制提供参考。更多还原

【Abstract】 Objective To establish an HPLC method for the determination of related substances in the raw drug substance of novel gonadotropin-releasing hormone（GnRH） antagonist LPM7100328.Methods An ACE Excel Super C₁₈（4.6 mm×150 mm, 3 μm） column was used. The mobile phase A consisted of 0.01 mol·L^-1 potassium dihydrogen phosphate aqueous solution（adjusting pH to 2.5 with phosphoric acid）, while acetonitrile-methanol（80∶20） was used as the mobile phase B,with gradient elution at a flow rate of 1.0 mL·min^-1. The detection wavelength was 248 nm, and the column temperature was 40 ℃. Results The peaks of LPM7100328 and each impurity were well separated, with good linearity in the linear self-concentration range. The detection limits for LPM7100328, and impurities A, B, and C were 0.0746, 0.0714, 0.0740, and 0.0741 μg·mL^-1,respectively. Conclusion The method is specific, sensitive and accurate, which is suitable for the determination of related substances in LPM7100328, and can provide a reference for subsequent study and quality control of LPM7100328.更多还原