Determination of residual organic solvent acetic acid in Omeprazole Magnesium by HPLC
LI Ju-ping
LIU Xiao-ping
JIN Yong-liang
Abstract：Objective To establish a method for the determination of residual acetic acid in Omeprazole Magnesium by HPLC Methods The X - Bridge TM C18(4. 6 mm × 250 mm,5 μm)column was adopted,temperature programming and FID detector was used. Results The solvent had good linear relationship and the precision and reproducibility of the meth-od were in accord with the requests. The linear range of acetic acid was 0. 01 ~ 0. 06 mg·mL - 1(r = 0. 999 994);The aver-age recovery rates of low,middle,high concentration(n = 9)were 100. 60% ,100. 38% ,100. 23% ,respectively and the RSDs were 2. 20% ,2. 21% ,1. 60% ,respectively;LOD was 0. 005 0 mg·mL - 1 . Conclusion This method could be used to determine residual acetic acid in Omeprazole Magnesium. The limit was not more than 0. 05%(500 ppm).
Keywords：HPLCOmeprazde MagnesiumSolvent residueDetermination
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 514-516 )