Determination and evaluation of furfural in furosemide and its tablets
Objective:To establish a method for determination genotoxic impurity furfural in furosemide and its tablets.To analyze and evaluate the measurement results to provide a reference for national drug supervision and ensure drug safety.Methods:The chromatographic column was filled with octadecylsilane bonded silica gel,and the gradient elution was performed with phosphoric acid solution and acetonitrile as the mobile phase.The detec-tion wavelength was 276 nm.The method was validated and used to determine the furfural content in 6 batches of furosemide and 148 batches of furosemide tablets.Results:The detection limit of furfural was 4 ng·mL-1and the quantitation limit was 12 ng·mL-1.The linearity between 0.012 0-0.602 3 μg·mL-1(r=1.000)was good.The average recoveries of furosemide and its tablets were 99.4％(RSD=0.99％)and 101.4％(RSD=1.3％).Furfural was detected in all batches of raw materials and tablet samples.The furfural content in the tablet products,which used the raw materials from company Ⅰ,was significantly higher than that of the prod-ucts obtained from company H.Conclusion:This method has strong specificity,high sensitivity and good accura-cy.It can be used for the determination of genotoxic impurity furfural in furosemide and its tablets.By analyzing the measurement results and discussing the sources and control strategies of furfural,quality control of furosemide tablets can be achieved.
national drug sampling inspectionfurosemidegenotoxic impurityfurfuralhigh performance liquid chromatography
NETL
NSTL
万方数据
