Equivalence of microbiological and hydroxylamine methods of analysis for ampicillin dosage forms.

Ampicillin formulations were assayed by microbiological and hydroxylamine methods to determine whether thehydroxylamine analytical method is a suitable substitute for the microbiological method. Paired assay results by the 2 analytical methods were obtained on different strengths of tablet, capsule, and suspension, formulations containing ampicillin and ampicillin degradation compounds. Several statistical tests were used to assess the equivalence of the paired assay results. The data analyses indicate that the hydroxylamine method is a suitable substitute for the microbiological method for potency assays and stability studies of ampicillin formulations. The hydroxylamine method yielded slightly higher assay results than the microbiological method for severely degraded formulations.