Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System

Vu, Nicole T; Aloumanis, Vasileios; Ben, Michel J; Kupiec, Thomas C; Patterson, Evelyn K; Radke, Joshua; Erickson, Martin A III; Schneider, Gary

Abstract

Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System

Author(s): Vu Nicole T, Aloumanis Vasileios, Ben Michel J, Kupiec Thomas C, Patterson Evelyn K, Radke Joshua, Erickson Martin A III, Schneider Gary

Issue: Nov/Dec 2008 - Arthritis and Immunological Diseases

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Page(s): 558-564

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Abstract

The objective of this study was to determine the stability of metronidazole benzoate suspension in SyrSpend SF One-Step Suspension System. The studied samples were packaged in 60-mL amber plastic prescription bottles, which were stored protected from light under controlled environmental conditions for a period of 360 days. Stability of metronidazole benzoate suspension in SyrSpend SF was assessed based on retention of initial color or appearance, pH of suspension, and recovery of metronidazole benzoate from the packaged product. Duplicate samples were evaluated at each predefined time interval. An assay method by high performance liquid chromatography was validated for its specificity and stability-indicating characteristics through a forced-degradation study, and was used in metronidazole benzoate assay. Metronidazole benzoate in SyrSpend SF retained its normal appearance of an opaque suspension, with acceptable pH values ranging from 4.43 to 4.53 (range 4.45 ± 0.5). Recovery of metronidazole benzoate at sub

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