反相HPLC法对奈达铂原料及其制剂的含量和有关物质的测定  

Determination of the content and the related substances of Nedaplatin crude drug and its injection by RP-HPLC

作　　者：鲁军 矫建 牛玉娟 

机构地区：[1]大连市药品检验所,辽宁大连116021

出　　处：《大连医科大学学报》2016年第6期549-552,共4页Journal of Dalian Medical University

摘　　要：目的探讨反相HPLC法测定奈达铂和注射用奈达铂的含量和有关物质的可行性。方法反相HPLC法检测5批奈达铂,3个规格7批注射用奈达铂的专属性与耐受性、线性关系、检出限、定量限、重复性与稳定性以及样品含量和有关物质。色谱条件：特定品牌C18柱;流动相为辛烷磺酸钠溶液-乙腈,流速1.0 m L/min,柱温40℃,检测波长220 nm。结果奈达铂浓度为0.025～4.00 mg/m L浓度范围内,与峰面积线性关系良好（相关系数r=0.9998）,检出限为0.05036μg/m L,定量限为0.1259μg/m L。结论反相HPLC法方法简便,结果准确,适用于对奈达铂和注射用奈达铂的质量控制。Objective To establish a RP- HPLC method for determination of contents of Nedaplatin and its related substances in Nedaplatin injection. Methods The RP- HPLC condition was consisted of a specific brand C18 column（ 4. 6 mm × 250 mm,5 μm） with a column temperature at 40 ℃,the mobile phase was octane sulfonic acid sodium solution（ the right amount of 0. 856 g octane sulfonic acid sodium dissolved by water,adding phosphate 0. 5 mL diluted to1000 mL）- acetonitrile（ 91∶ 9）,with a flow rate of 1. 0 mL / min and detection at 220 nm. Results Nedaplatin showed good linearity in the range of 0. 025- 4. 000 mg / mL（ r = 0. 9998）. The limit of detection and quantitation was0. 05036 μg / mL and 0. 1259 μg / m L respectively. Conclusion The RP- HPLC method would be simple and applicable for the quality control of Nedaplatin crude drug and its injection.

关 键 词：反相HPLC法 奈达铂和注射用奈达铂 含量测定 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]