Suitability of a liquid chromatography assay of neomycin sulfate to replace the microbiological assay for neomycin in USP Monographs |
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Authors: | Valoran P Hanko Jeffrey S Rohrer |
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Institution: | Dionex Corporation, 1214 Oakmead Parkway, Sunnyvale, CA 94088-3603, USA |
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Abstract: | The current USP National Formulary contains 65 Monographs for drug formulations containing neomycin. All 65 Monographs prescribe a bioassay for neomycin assay. This bioassay, based on cell culture, is labor intensive, has poor precision, and cannot be adapted for purity or identification. High-performance anion-exchange chromatography with integrated pulsed amperometric detection (HPAE-IPAD), a liquid chromatography technique, has been shown to be suitable for neomycin purity analysis and neomycin assay of an over-the-counter first aid cream (Hanko and Rohrer 17]). Here we propose that an HPAE-IPAD assay can replace the bioassay in the 65 neomycin-containing Monographs. We applied the HPAE-IPAD assay to four neomycin-containing drug products representing the four classes of formulations found in the 65 Monographs, liquid, solid, suspension, and cream. Each drug was analyzed with two chromatography systems, and on 3 separate days. For all products, HPAE-IPAD measurements were precise and accurate with respect to the label concentrations. There was also high accuracy for spike recovery of neomycin from the four drug products throughout 70–150% of the labeled concentration. These results suggest that an HPAE-IPAD assay would be an accurate assay for neomycin, and would be faster and more precise than the current bioassay. |
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Keywords: | HPAE-PAD HPAE-IPAD Neomycin sulfate Aminoglycoside Antibiotic Amperometric Amperometry Electrochemical Anion-exchange Chromatography Neosporin Cortisporin Ophthalmic Suspension Irrigant Ointment Gel Cream Pharmaceutical |
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