猪尿冻干粉中盐酸克伦特罗标准物质的研制

Development of reference materials of clenbuterol hydrochloride in swine urine lyophilisate

研制一套4种浓度水平的猪尿冻干粉中盐酸克伦特罗标准物质,以健康安全的猪尿作为空白基体,利用添加的方法,经过均匀性和稳定性检验,由8家实验室采用液相色谱-串联质谱法对该套标准物质进行协同定值,并进行不确定度评估。结果表明该套标准物质均匀性良好,在4℃条件下保存稳定性在1年以上,标准物质中CLB的含量及不确定度分别为:0.65±0.15,1.28±0.44,3.78±0.46,11.5±1.8ng/mL(k=2)。该标准物质可应用于猪尿中盐酸克伦特罗检测过程的方法验证和检测结果质量控制等。

Reference materials （RMs） of clenbuterol hydrochloride （CLB） in lyophilized swine urine powder were developed by spiking CLB stock solution into healthy, safe and CLB-free swine urine. The homogeneity and the stability of the RMs were strictly inspected. The concentration of the RMs was certified using LC-MS/MS method by 8 different laboratories, and the uncertainty evaluation was performed finally. The analysis results showed that the RMs were homogeneous and stable for at least one year in 4 ℃. The certified value and expanded uncertainty of the RMs were as following： 0.65±0.15, 1.28±0.44, 3.78±0.46, 11.5 ±1.8ng/mL respectively （k=2）. These RMs were intended for CLB analysis method validation and quality control.