A high pH based reversed-phase high performance liquid chromatographic method for the analysis of aminoglycoside plazomicin and its impurities

Journal of Pharmaceutical and Biomedical Analysis
Li TanDane E Karr

Abstract

A reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the aminoglycoside (AG) plazomicin (ACHN-490). This method employed a high pH mobile phase (pH>11) with a gradient of 0.25 M ammonium hydroxide in water and acetonitrile, an XBridge C(18) column and UV detection at 210 nm. Although the molar UV absorption of plazomicin is weak, the high pH conditions of this method allow for higher loadings, which compensates for the inherent low UV sensitivity. Under these high pH conditions, impurities and degradants were base line separated from plazomicin. The mobile phases used for this method allowed for on-line mass detection for the impurities and degradants. The RP-HPLC method has been validated in terms of specificity, linearity and range, accuracy, and precision. The analytical method met specificity requirements of a homogenous peak with no interferences from the blank or from the known impurities in plazomicin. The linearity of the method for the plazomicin impurity determination was excellent, with a coefficient of determination (r(2)) of 0.9993, over the freebase (FB) concentration range of 0.0025-3.0 mg/mL. The method is capable of detecting impurities down to 0.1% of the peak area o...Continue Reading

References

Mar 27, 2004·Journal of Chromatography. a·Uwe Dieter NeueDiane M Diehl
Sep 23, 2009·Antimicrobial Agents and Chemotherapy·Andrea EndimianiRobert A Bonomo
Sep 2, 2010·Antimicrobial Agents and Chemotherapy·James B AggenHeinz E Moser

Citations

Aug 24, 2013·Journal of Pharmaceutical and Biomedical Analysis·Deepti Jain, Pawan Kumar Basniwal
Sep 9, 2015·Analytica Chimica Acta·Faten FaroukWilfried M A Niessen
Apr 17, 2015·Journal of Pharmaceutical and Biomedical Analysis·Kenneth B WlasichukDonald E Schmidt

Related Concepts

Plazomicin
Antibiotics
High Pressure Liquid Chromatography Procedure
Drug Impurity
Hydrogen-Ion Concentration
Siseptin
Mass Spectrometry
Limit of Detection
Molar Tooth
Acetonitrile

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Aminoglycoside is a medicinal and bacteriologic category of traditional Gram-negative antibacterial medications that inhibit protein synthesis and contain as a portion of the molecule an amino-modified glycoside. Discover the latest research on aminoglycoside here.