Purpose:To establish a HPLC testing method of the content of bulk picoplatin and its impurities.Method:the separation was perform on a C18 column(4.6 mm×250 mm,5 μm) with potassium dihydrogen phosphate-aceton-itrile as the mobile phase at a flow rate of 1.0 mL/min.The detecting wavelength was set at 210 nm,and the column temperature was set at 30℃.Result:in the method validation,the linear relationship modulus of picoplatin is 0.9999,the systemic precision is 0.44％,the method precision is 0.74％,the average recovery rate is 99.62％,the LOD and LOQ of picoplatin is 0.2 ng and 1.0 ng.The average resolution of picoplatin and its impurities is more than 2.Conclusion:The established method is good specificity,high sensitivity,and good repeatability which could provide scientific evidence for the quality control ofpicoplatin and its impurities.
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