摘要
目的:统一规范维生素B_(1)片质量标准,优化有关物质检测方法,简化操作,保证试验结果真实可靠。方法:采用AiChrom-C18色谱柱(4.6 mm×250 mm,5μm),以3.764 g/L己烷磺酸钠(磷酸调节pH值为3.1)为流动相A,甲醇∶乙腈(1∶1)为流动相B,梯度洗脱,对维生素B_(1)有关物质进行分离;采用加校正因子的主成分自身对照法对维生素B_(1)中的8个已知杂质进行定性和定量分析。结果:维生素B_(1)与有关物质分离良好。17家企业生产的维生素B_(1)片检出11种杂质。结论:建立的方法专属性良好,可有效地分离和测定维生素B_(1)片中的有关物质。本研究为维生素B_(1)有关物质杂质谱的研究提供科学参考。
Purpose:To standardize the quality standards of vitamin Bi tablets,optimize the detection methods of related substances,simplify operations,and ensure the authenticity and reliability of test results.Method:An Ai-Crom-C18 chromatographic column(4.6 mm×250 mm,5μm)is used,with 3.764 g/L sodium hexanesulfonate(pH adjusted to 3.1 with phosphoric acid)as the mobile phase A,Methanol:Acetonitrile(1:1)as mobile phase B_(1) gradient elution,to separate vitamin B_(1) related substances;Qualitative and quantitative analysis of 8 known impurities in vitamin B_(1) was conducted using principal component self comparison method with added correction factors.Result:Vitamin B_(1) was well separated from related substances.Eleven impurities were detected in vitamin B,tablets produced by 17 companies.Conclusion:The established method has good specificity and can effectively isolate and determine the relevant substances in vitamin B,tablets.This study provides scientific reference for the study of impurity spectra of vitamin B related substances.
作者
郑露盼
何亚芬
方文超
丁金有
张继红
ZHENG Lupan;HE Yafen;FANG Wenchao;DING Jinyou;ZHANG Jihong(Drug Testing Branch of Shangrao Inspection,Testing and Certification Institute,Shangrao 334000,China;Product Quality Testing Branch of Shangrao Inspection,Testing and Certification Institute,Shangrao 334000,China)
基金
江西省药品监督管理局科研项目(2023JS22)。
