Quantitative determination method for trace amount of penicillin contaminants in commercially available drug product by HPLC coupled with tandem mass spectrometry

Wataru Takada, Toshikazu Adachi, Noriaki Kihara, Satoshi Kitamura, Teruyuki Kitagawa, Masaki Mifune, Yutaka Saito

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

A quantitative determination method for trace amount of penicillin contaminants in an active pharmaceutical ingredient (API) has been developed. Selective extraction of penicillin contaminants from the matrix containing API and specific separation among penicillin contaminants were achieved through an on-line column switching technique with gradient elution, followed by tandem mass spectrometric determination. Validation was conducted on the developed method in terms of specificity, linearity, accuracy, precision, and detection limit, and appeared reasonable. The detection limit was estimated as 0.03 ng/ml or lower of the concentration of penicillin contaminants in the preparation, corresponding to 4 parts par billion (ppb) against the API. This fulfilled the regulatory requirement by the authorities.

Original languageEnglish
Pages (from-to)172-176
Number of pages5
JournalChemical and Pharmaceutical Bulletin
Volume53
Issue number2
DOIs
Publication statusPublished - Feb 1 2005

Keywords

  • Commercially available drug product
  • Penicillin contaminant
  • Quantitative determination
  • Trace amount (ppb)

ASJC Scopus subject areas

  • Chemistry(all)
  • Drug Discovery

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