高效液相色谱法测定奥沙利铂的左旋异构体  

HPLC determination of levoisomer of oxaliplatin

作　　者：余邦良[1] 杨柳 马亚平 

机构地区：[1]海南医学院化学教研室,海口571101 [2]海南中和集团多肽药物研究所,海口570216

出　　处：《药物分析杂志》2006年第5期696-698,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立一种能够有效地测定奥沙利铂左旋异构体的高效液相色谱法。方法:称取2份适量的外消旋体草酸铂,一份用去离子水溶解,另一份用流动相溶解,均配制成1.0mg·mL^(-1)的溶液;另称取2份一定量的奥沙利铂,一份用去离子水溶解,另一份用流动相溶解,均配制成1.0mg·mL^(-1)的溶液。色谱条件:手性色谱柱为日本 Daicel 化学工业公司 Chiralcel OC(250mm×4.6mm,10μm),填料为甲氨酸酯纤维素衍生化合物吸附硅胶;流动相为甲醇-乙醇(70:30);流速为0.5mL·min^(-1);检测波长为250nm;柱温为室温;进样量20μL。结果:样品用流动相溶解测得奥沙利铂与其左旋异构体的分离度为3.4,理论塔板数为6498,而且峰形好,不出倒峰,符合奥沙利铂的质量标准规定。而样品用水溶解测得奥沙利铂与其左旋异构体的分离度为1.4,理论塔板数为1246,峰形不好,有倒峰,不符合奥沙利铂的质量标准规定。结论:建立了一种能够有效地测定奥沙利铂左旋异构体的高效液相色谱法。Objective：To develop an effective method for determination of levoisomer of oxaliplatin by HPLC. Method： Two portions of quantitive racemic oxaliplatin were weighed, one was dissolved by deionzed water, the other was dissolved by mobile phase. Both of concentration were 1.0 mg ·mL^-1. Two portions of quantitive oxaliplatin were weighed, one was dissolved by deionzed water,the other was dissolved by mobile phase. Both of concentration were also 1.0 mg ·mL^-1. Chromatographic condition：chiral chromatographic column was Chiralcel OC （250 mm × 4. 6 mm, 10 μm）. The column contains a carbamate cellulose derivative coated silica -gel as the packing material of Daicel chemical industry company of Japan ;The mobile phase was methanol -ethanol（70： 30） ;The flow rate was 0. 5 mL ·min^-1 ;The detector was set at 250 nm; Column temperature was room temperature; Injection volume was 20 μL. Result： The resolution was 3.4, the number of theoretical plates was 6498 and the peak form was good and there was no reversal peak when the sample was dissolved by the mobile phase. The result was consistent with the regulation of quality criteria of oxaliplatin. Howerever, the resolution was 1.4, the number of theoretical plates aws 1246 and the peak form was not good and there was reversal peak when the sample was dissolved by deionzed wa- ter. The result was not consistent with the regulation of quality criteria of oxaliplatin. Conclusion： An effective method for determination of levoisomer of oxaliplatin by HPLC is developed.

关 键 词：奥沙利铂 左旋异构体 分离度 理论塔板数 峰形 

分 类 号：R917[医药卫生—药物分析学]