HPLC法测定盐酸贝凡洛尔原料药中的有关物质及其方法学验证OA

Objective:To establish and validate a high-performance liquid chromatography(HPLC)method for the determination of related substances in bevantolol hydrochloride bulk drug substance.Methods:A CAPCELL PAK MG Ⅱ C18 column(4.6 mm ×250 mm,5 μm)was used with mobile phase A consisting of phosphate buffer(pH 6.0)-methanol(20∶80)and mobile phase B of phosphate buff-er-methanol(90∶10)in a gradient elution mode.The flow rate was 1.0 mL·min-1,the detection wavelength was set at 280 nm,and the column temperature was maintained at 30℃.Results:Baseline separation was achieved between bevantolol hydrochloride and eight known impurities(A-H).The resolution between each impurity and the main peak,as well as between the impurities themselves,was greater than 1.5.All impurities showed good linearity within their respective concentration ranges(R2＞0.999).The average recovery ranged from 95.9％to 102.7％with an RSD values are all less than or equal to 5.97％(n=9).The test solution remained stable at room temperature for 8 h.The method demonstrated good precision:the content ranges for impurity C,other individual impurities,and to-tal impurities in 12 samples were 0.007％,0.005％and 0.016％,respectively.Conclusion:The established method is specific,sensi-tive,accurate,and precise.It is suitable for the determination of related substances in bevantolol hydrochloride raw material and provides a reliable analytical basis for its quality control.