Study On The Quality Standard Of Oxaliplatin For Injection

Objective:The main aim of this thesis was to contribute to the quality standard study of oxaliplatin for injection including characters, identification, test and assay.Method:In this study, the characters, identification, test and content determination of oxaliplatin were studied.The related substances were analyzed by HPLC. The method established for the analysis of related substances, oxalic acid, diaquodiaminocyclohexaneplatinum and its dimer, dihydroxyplatinum and the related substances, is as follows.(1) Oxalic acid. The sample was analyzed by C18column, and the mobile phase was composed of acetonitrile (mobile phase A) and phosphate buffer (mobile phase B)(A:B=20:80V/V). The UV detector was set at205nm, the column temperature was maintained at40℃.(2) Diaquodiaminocyclohexaneplatinum and its dimer. The sample was analyzed by C18column, and the mobile phase was composed of acetonitrile (mobile phase A) and phosphate buffer (mobile phase B)(A:B=20:80V/V). The UV detector was set at215nm. the column temperature was maintained at40℃(3) Dihydroxyplatinum and the related substances. The sample was analyzed by C18column, and the mobile phase was composed of acetonitrile (mobile phase A) and phosphate buffer (mobile phase B)(A:B=1:99V/V). The UV detector was set at210nm, the column temperature was maintained at40℃.HPLC method was used for the content determination of oxaliplatin for injection. The sample was analyzed by C18column, and the mobile phase was composed of acetonitrile (mobile phase A) and phosphate buffer (mobile phase B)(A:B=1:99V/V). The UV detector was set at210nm, the flow rate was1.2ml/min, and the column temperature was maintained at40℃. Meanwhile, the stability of oxaliplatin for injection was also investigated.Results:The main results relating the study of study of oxaliplatin for injection were as follows:(1) The characters:white or almost white, crystalline powder. The maximum UV absorbance wavelength is249nm, and the minimum is243nm. The solution is clear and colorless. The pH is5.0-7.0.(2) The related substances:The area of oxalic acid was less than0.3%of the principal peak in the chromatogram obtained with reference solution. The area of diaquodiaminocyclohexaneplatinum and its dimer were less than0.4%and0.2%of the principal peak in the chromatogram obtained with reference solution separately. The area of dihydroxyplatinum and the related substances was less than0.2%of the principal peak in the chromatogram obtained with reference solution. The area of total impurities was less than1.0%of the principal peak.(3) The content determination method:The HPLC method established for the content determination of oxaliplatin for injection was simple and fast, with high sensitivity, accuracy and repeatability.(4) The stability of oxaliplatin for injection. The results showed that oxaliplatin for injection was stable and could maintain its quality for two years kept under25℃Conclusion:The methods established for the characterization, identification, related substance test, and content determination of oxaliplatin for injection were feasible and practical. The drafted Quality Standard based on the study could be used for the quality control of oxaliplatin for injection.