title: High-performance liquid chromatographic method for potency determination of amoxicillin in commercial preparations and for stability studies.
abstract: A reversed-phase column liquid chromatographic method was developed for the assay of amoxicillin and its preparations. The linear calibration range was 0.2 to 2.0 mg/ml (r = 0.9998), and recoveries were generally greater than 99%. The high-performance liquid chromatographic assay results were compared with those obtained from a microbiological assay of bulk drug substance and capsule, injection, and granule formulations containing amoxicillin and degraded amoxicillin. At the 99% confidence level, no significant intermethod differences were noted for the paired results. Commercial formulations were also analyzed, and the results obtained by the proposed method closely agreed with those found by the microbiological method. The results indicated that the proposed method is a suitable substitute for the microbiological method for assays and stability studies of amoxicillin preparations.
authors.affiliation: Department of Health, Executive Yuan, National Laboratories of Foods and Drugs, Taipei, Taiwan, Republic of China.
authors.forename: M C
authors.initials: MC
authors.lastname: Hsu
authors.forename: P W
authors.initials: PW
authors.lastname: Hsu
mesh_terms: D000658:Amoxicillin / Q000032:analysis* / Q000494:pharmacology; D001412:Bacillus subtilis / Q000187:drug effects; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007202:Indicators and Reagents; D008826:Microbial Sensitivity Tests
chemical_list: D007202:Indicators and Reagents; D000658:Amoxicillin