تحليل شوائب سلفات الجنتاميسين الحقني باستخدام طريقة الاستشراب السائل بالطور العكوس و متحري مطياف الكتلة LC (RP)‎ MS

الملخص EN

Liquid chromatography coupled with Mass spectrometry LC/MS was used for determination the components of Gentamicin، identification of its impurities, and impurity profiling of Gentamicin sulfate injections locally produced.

The method was achieved on a C18 column and 50mM trifluoroacitic acid (TFA)، pH = 2 adjusted with ammonium solution، as a mobile phase at a flow rate of 0.25 mL/min.

The developed method provides a complete base line for the separation of the components C1, C1a, C2, C2a and C2b of Gentamicin sulfate from each other and from present nine impurities ( Garamine, Gentamicin A, Gentamicin B, Gentamine C2, JI20- A, Gentamicin B1, Sisomicin, JI20-B, Gentamine C1), and the mass spectrometry gives an idea about percentage of gentamicin components.

Electron spray ionization (ESI) source in the positive ion mode was used.

Nine impurities in gentamicin were identified by this method، in addition to a reference impurity was not presented in any investigated sample, and detection limits for Gentamicin and G – 418 were calculated.

Reference compounds were: sisomicin ، G-418 ، gentamicin sulfate.

The method was validated in accordance to International Conference of Harmonization (ICH) guidelines acceptance criteria and the United States Pharmacopoeia 34(USP) for category (2): Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products.

The investigated commercial samples were from different origins: local and foreign.