Specific High-Performance Liquid Chromatographic Determinatioin of Ampicillin in Bulks, Injectables, Capsules, and Oral Suspensions by Reverse-Phase Ion-Pair Chromatography

Publisher Website
Google Scholar
Abstract
A rapid, specific, stability-indicating high-performance liquid chromatographic (HPLC) method was developed for the assay of ampicillin [an antibiotic] in ampicillin trihydrate bulk, capsules and oral suspensions and sodium ampicillin bulk and injectables. The assay is specific for ampicillin in the presence of possible contaminants; penicillin V, phenylglycine, and 6-aminopenicillanic acid (6-APA); the degradation product, penicilloic acid of ampicillin; and all excipients present in the formulations assayed. Ampicillin, ampicillin formulations and formulation excipient blends were force-degraded to further demonstrate specificity. The assay is precise, accurate, linear over the range 50-125% of expected ampicillin sample level, and stability-indicating toward the described thermal, acid, base, aqueous and light degradations. The procedure employs an ion-pairing eluent with UV detection at 254 nm. Ampicillin trihydrate and sodium ampicillin bulk are stable in assay diluent for 6 h allowing the use of automatic HPLC injectors for unattended analysis. One set of HPLC parameters can assay bulks and formulations.