Impurity Analysis of Gentamicin Sulphate Injection UsingLiquid Chromatography/Mass Spectrometry LC / MS

Abstract

Gentamicin sulfate (GEN) is a broad-spectrum belonging to the group of aminoglycosides (AGs). The objective of
the current study is the analysis of GEN injection impurity using reverse-Phase liquid chromatography and mass
spectrometry. Five samples of GEN injection were selected from Abb governorate,and analyzed by LC/MS. The
result showed that the Inj-I sample contained nineteen known impurities; m/z163 deoxystreptamine, m/z 322
garamine, m/z 319 gentamine C1, VII-2, XK-62-5, Y-02077H- δ, gentamicin C1a in m/z 450, Y-02077H-γ, XK-62-3,
VII-1, gentamicins C2, C2a, and C2b in m/z 464 and m/z 478 gentamicin C1,garosamine m/z 177, m/z 448
sisomicin, at m/z 492 Y-02077H-β, XK-62-7and XK-62-8. In Inj-II sample showed fourteen impurities same
impurities as in the Inj-I sample except for gentamineC1 m/z 319 and impurities in m/z 492, and garosamine in
m/z 177. While Inj-III samples showed fifteen impurities same impurities as in the Inj-I sample except for
impurities in m/z 492 and m/z 177. In Inj-IV sample showed nineteen impurities same impurities as in the Inj-III
sample except for m/z 448 sisomicin and impurity m/z482 J1-20A. In Inj-VI sample showed eighteen impurities
same impurities as in the Inj-I Rehaf sample except for garosamine in m/z 177. In addition of two unknown
impurities in 490 and 110 except the Inj-II sample did not show these impurities.