Quantitative determination method for trace amount of penicillin contaminants in commercially available drug product by HPLC coupled with tandem mass spectrometry |
| |
Authors: | Takada Wataru Adachi Toshikazu Kihara Noriaki Kitamura Satoshi Kitagawa Teruyuki Mifune Masaki Saito Yutaka |
| |
Affiliation: | Analytical Research Laboratories, Fujisawa Pharmaceutical Co., Ltd, Osaka, Japan. |
| |
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. |
| |
Keywords: | |
本文献已被 PubMed 等数据库收录! |
|