采用化学发光流动注射分析法测定制药生产设施中的头孢美唑残留量。

Determination of cefmetazole residue at pharmaceutical manufacturing facilities by chemiluminescence flow injection analysis.

作者信息

Fukutsu Naoto, Konse Tomonori, Kawasaki Takao, Saito Koichi, Nakazawa Hiroyuki

机构信息

Analytical and Quality Evaluation Research Laboratories, Sankyo Co. Ltd., 1-12-1 Shinomiya, Hiratsuka-shi, Kanagawa 254-0014, Japan.

出版信息

J Pharm Biomed Anal. 2006 May 3;41(2):599-602. doi: 10.1016/j.jpba.2005.11.038. Epub 2006 Jan 18.

DOI:10.1016/j.jpba.2005.11.038

PMID:16413735

Abstract

Application of a sensitive and rapid flow injection analysis (FIA) method with luminol chemiluminescence detection for determination of trace amounts of cefmetazole (CMZ) in cephamycin antibiotic residue in pharmaceutical manufacturing facilities and on pharmaceutical manufacturing equipment has been investigated. The method was shown to be sensitive at a level of limit of detection of 0.06 ng/ml and for linear concentrations in the range of 0.3-1.5 ng/ml. Average recoveries of CMZ from stainless steel plates and glass plates were 62.1% and 60.1%, respectively, by adding 15 ng/100 cm2, and that of air sampling filters was 91.9% by adding 3 ng/filter. The proposed method has been successfully applied to the determination of CMZ residue in samples collected from an actual manufacturing facility and equipment. According to the results, no detectable CMZ residue was observed, therefore it was verified that no contamination had occurred to other pharmaceutical products manufactured in the facility.

摘要

研究了一种采用鲁米诺化学发光检测的灵敏快速流动注射分析（FIA）方法，用于测定制药生产设施和制药生产设备中头孢霉素抗生素残留中的痕量头孢美唑（CMZ）。该方法在检测限为0.06 ng/ml时表现出灵敏性，线性浓度范围为0.3 - 1.5 ng/ml。通过添加15 ng/100 cm²，从不锈钢板和玻璃板中回收CMZ的平均回收率分别为62.1%和60.1%，通过添加3 ng/过滤器，空气采样过滤器的回收率为91.9%。所提出的方法已成功应用于从实际生产设施和设备收集的样品中CMZ残留的测定。根据结果，未观察到可检测到的CMZ残留，因此证实该设施生产的其他药品未发生污染。