医学信息
醫學信息
의학신식
MEDICAL INFORMATION
2014年
9期
538-539
,共2页
王立标%王立志%张明法
王立標%王立誌%張明法
왕립표%왕립지%장명법
奥沙利铂%相关物质%反相高效液相色谱法
奧沙利鉑%相關物質%反相高效液相色譜法
오사리박%상관물질%반상고효액상색보법
Oxaliplatin%Related substances%RP-HPLC
目的：高效液相色谱法分离测定奥沙利铂相关物质。方法 RP-HPLC色谱条件：色谱柱为Agilent SB-C18(250 mm×4.6 mm，5μm)，柱温35℃；以乙腈-磷酸盐缓冲液为流动相，进行梯度洗脱；流速为1.0 mL/min；检测波长205 nm。结果确定了奥沙利铂合成中可能引入的杂质 A和奥沙利铂的出峰位置。结论注射用奥沙利铂对温度敏感，应冷藏储存。
目的：高效液相色譜法分離測定奧沙利鉑相關物質。方法 RP-HPLC色譜條件：色譜柱為Agilent SB-C18(250 mm×4.6 mm，5μm)，柱溫35℃；以乙腈-燐痠鹽緩遲液為流動相，進行梯度洗脫；流速為1.0 mL/min；檢測波長205 nm。結果確定瞭奧沙利鉑閤成中可能引入的雜質 A和奧沙利鉑的齣峰位置。結論註射用奧沙利鉑對溫度敏感，應冷藏儲存。
목적：고효액상색보법분리측정오사리박상관물질。방법 RP-HPLC색보조건：색보주위Agilent SB-C18(250 mm×4.6 mm，5μm)，주온35℃；이을정-린산염완충액위류동상，진행제도세탈；류속위1.0 mL/min；검측파장205 nm。결과학정료오사리박합성중가능인입적잡질 A화오사리박적출봉위치。결론주사용오사리박대온도민감，응랭장저존。
Objective:To develop an HPLC method for the separation of Oxaliplatin for injection and its known related compound. Method:The analysis was conducted on Agilent SB-C18 (250mm×4.6mm,5μm)with a mobile phase of acetonitrile-phosphate buf er by gradient elution at a flow of 1.0 mL·min-1.The detection wavelength was 205 nm. Results:The retention time of Oxaliplatin and relevant impurity A are determined. The impurity A has been found levels below 0.1% in the Oxaliplatin for injection. Conclusion:The Oxaliplatin for injection is sensitive to temperature and should be refrigerated storage.
