摘要
目的:建立HPLC法测定氨咖黄敏胶囊中的有关物质对氨基酚的含量。方法:采用C18色谱柱,以磷酸盐缓冲液(磷酸二氢铵11.5 g,加水溶解,加磷酸1 mL,加水至1000 mL)-乙腈(88:12)为流动相,检测波长为262 nm,流量为1.0 mL.min-1。结果:有关物质对氨基酚的浓度在0.2058～40.5524μg.mL-1范围内与峰面积呈良好线性关系(r=0.9999),对氨基酚与药物中的各成分有效分离,对氨基酚的最低检测限为20 ng.mL-1。结论:该方法灵敏、准确,能够检出氨咖黄敏胶囊中的对氨基酚,可用于该药品的质量控制。
Objective： To establish an RP-HPLC method for determination of the related substance 4-aminophenol in Anka HuangminCapsules. Method： Chromatographic separation was achieved on the Alltima Cls column using phosphate buffer solution and acetoni- trile （88： 12） as a mobile phase,and the flow rate was 1 mL · min-1 , the detective wavelength was 262 ran. Resuits： The linear range of the related substance 4-aminopbenol was 0. 2058-40. 5524 μg · mL-1 （r =0. 9999）, the effective components in the capsules and 4-a- minophenol can be well separated. The lowest detection limit of 4-aminophenol was 20 ng · mL-1. Conclusion： The RP-HPLC method was sensitive, specific for the determination of 4-aminophenol in Anka Huangmin Capsules. , and can be used for the quality control.
出处
《中国药品标准》
CAS
2013年第2期97-100,共4页
Drug Standards of China
