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

关键词:  反相HPLC法  奈达铂和注射用奈达铂  含量测定

Key words:  RP-HPLC  Nedaplatin crude drug and its injection  content determination

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 mL/min，柱温40 ℃，检测波长220 nm。结果　奈达铂浓度为0.025～4.00 mg/mL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0.05036 μg/mL，定量限为0.1259 μg/mL。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。

Abstract:

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 to 1000 mL)- acetonitrile (91∶[KG-*2]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 was 0.05036 μg/mL and 0.1259 μg/mL respectively.Conclusion　The RP-HPLC method would be simple and applicable for the quality control of Nedaplatin crude drug and its injection.