论文部分内容阅读
目的建立检测重组人干扰素α2b(recombinant human interferonα2b,rhIFNα2b)注射液中组氨酸含量的高效液相色谱(high performance liquid chromatography,HPLC)法,并对方法进行验证及初步应用。方法按设定的色谱条件对检测rhIFNα2b注射液中组氨酸含量的HPLC法进行专属性、系统适应性、试验内和日间精密性、准确性验证,确定方法的线性范围和最低检测限,并用建立的方法检测6批rhIFNα2b注射液中的组氨酸含量。结果该方法专属性、系统适应性、试验内精密性、日间精密性和准确性良好;线性范围为6.064 5~775μg/ml(R2=0.999 8);最低检测限为50 ng/ml;用建立的方法检测6批rhIFNα2b注射液中组氨酸含量与标示浓度接近。结论建立的HPLC法准确可靠,可用于rhIFNα2b注射液中组氨酸含量的测定。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of histidine in recombinant human interferon α2b (rhIFNα2b) injection and to validate the method and its preliminary application. Methods According to the chromatographic conditions, the HPLC method for the determination of histidine in rhIFNα2b injection was used to verify the specificity, system suitability, intra- and inter-day precision and accuracy of the method, and the linear range and minimum detection limit of the method were determined. The contents of histidine in six batches of rhIFNα2b injection were detected by the established method. Results The method specificity, system adaptability, intra-assay precision, daytime precision and accuracy were good. The linear range was 6.064 5-775μg / ml (R2 = 0.999 8). The lowest detection limit was 50 ng / ml. The established method to detect six batches of rhIFNα2b injection Histidine content and labeling concentration close. Conclusion The established HPLC method is accurate and reliable and can be used for the determination of histidine in rhIFNα2b injection.