Quantitative Determination Method for Trace Amount of Penicillin Contaminants in Commercially Available Drug Product by HPLC Coupled with Tandem Mass Spectrometry

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概要

• 論文の詳細を見る

• 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.

• 公益社団法人日本薬学会の論文
• 2005-02-01

著者

• Saito Yutaka

  Department Of Pharmaceutical Sciences Graduate School Of Medicine And Dentistry And Pharmaceutical S

• Saito Y

  Department Of Pharmaceutical Sciences Graduate School Of Medicine And Dentistry And Pharmaceutical S

• SAITO YUTAKA

  Faculty of Pharmaceutical Sciences, Okayama University

• MIFUNE Masaki

  Faculty of Pharmaceutical Sciences, Okayama University

• Kitagawa Teruyuki

  Analytical Research Laboratories Fujisawa Pharmaceutical Co. Ltd.

• Kitagawa Teruyuki

  Analytical Research Laboratories Fujisawa Pharmaceutical Co. Ltd

• Mifune Masaki

  Department Of Pharmaceutical Sciences Graduate School Of Medicine And Dentistry And Pharmaceutical S

• Mifune Masaki

  Faculty Of Pharmaceutical Sciences Okayama University

• Takada Wataru

  Analytical Research Laboratories Fujisawa Pharmaceutical Co. Ltd.

• Kihara N

  Osaka Univ. Osaka Jpn

• Kitamura Satoshi

  Analytical Research Laboratories Fujisawa Pharmaceutical Co. Ltd.

• ADACHI Toshikazu

  Biopharmaceutical and Pharmacokinetic Research Laboratories, Fujisawa Pharmaceutical Co., Ltd.

• KIHARA Noriaki

  Biopharmaceutical and Pharmacokinetic Research Laboratories, Fujisawa Pharmaceutical Co., Ltd.

• Adachi Toshikazu

  Biopharmaceutical And Pharmacokinetic Research Laboratories Fujisawa Pharmaceutical Co. Ltd.

• Saito Yutaka

  Faculty Of Engineering Kanazawa University

• KITAGAWA Teruyuki

  Analytical Research Laboratories, Fujisawa Pharmaceutical Co., Ltd.

• Saito Yutaka

  Department of Pharmaceutical Sciences, Graduate School of Medicine and Dentistry and Pharmaceutical Sciences, Okayama University

• Mifune Masaki

  Department of Pharmaceutical Sciences, Graduate School of Medicine and Dentistry and Pharmaceutical Sciences, Okayama University

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