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HIGH PERFORMANCE LIQUID CHROMATOGRAPHY OF GENTAMICIN SULFATE REFERENCE STANDARDS AND INJECTION USP

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Author(s): CHUONG M.C. | CHIN J. | HAN J.W. | KIM E. | ALHOMAYIN W. | AL DOSARY F. | RIZG W. | MOUKHACHEN O. | WILLIAMS D.A.

Journal: International Journal of Pharmaceuticals Analysis
ISSN 0975-3079

Volume: 4;
Issue: 1;
Start page: 25;
Date: 2013;
Original page

Keywords: o-phthalaldehyde solution | Aqua C18 | Luna C18 | Nuc leosil C18 | pre-column derivatization | sodium 1-heptanesulfonate.

ABSTRACT
The USP-NF 2013 describes 4 aminoglycoside chromatography peaks with an elution order of C1, C1a, C2a and C2. The method calculates gentamicin sulfate from a single standard concentration. The USP method for Gentamicin Sulfate Injection is a microbial assay, not a HPLC method. Therefore, the purposes were to evaluate the performance of different C18 columns for separating the aminoglycosides in the USP reference standard, a gentamicin sulfate powder met USP testing specifications, and a commercial injection product, and to construct a multi-point standard curve for calculating each of aminoglycosides rather than from a single concentration. Three LC columns from the same manufacturer were selected: (1) AquaÃ’ C18, 5 micron, (2) LunaÃ’ C18, 5 micron, and (3) Nuc leosilÃ’ C18, 3 micron (all in 4.6 x 150 mm). When samples prepared from a gentamicin sulfate powder met the USP test specifications were injected, only one peak at 8.8 min was displayed in the 35-min runtime chromatograms for Aqua C18 column, while three peaks were displayed for the Nuc leosil C18 column, and four peaks for the Luna column. Standard linearity was obtained from 0.2 to 2 mg/mL. Using the Luna column, the aminoglycosides eluded from the samples prepared from the USP Reference Standard and from a commercial injection USP were noted as three.
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