Fukutsu Naoto, Sakamaki Yuich, Kawasaki Takao, Saito Koichi, Nakazawa Hiroyuki
Analytical and Quality Evaluation Research Laboratories, Sankyo Co., Ltd., Kanagawa, Japan.
Chem Pharm Bull (Tokyo). 2006 Oct;54(10):1469-72. doi: 10.1248/cpb.54.1469.
Cross-contamination is a critical issue for pharmaceutical manufacturing, especially for beta-lactam antibiotics. Thus, an analytical method for the simultaneous determination of beta-lactam antibiotics cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in non-beta-lactam pharmaceuticals was developed using high-performance liquid chromatography-tandem mass spectrometry. The developed method was found to be sensitive at the detection limit of 0.002 ppm for both compounds. Mean recoveries of CMZ and CPDXPR from olmesartan medoxomil (OLM) tablets were 96.7 to 102.2% and 88.9 to 94.2%, respectively. The developed method was successfully applied for the verification of CMZ and CPDXPR contamination to actually manufactured OLM tablets.
交叉污染是制药生产中的一个关键问题，尤其是对于β-内酰胺类抗生素。因此，开发了一种使用高效液相色谱-串联质谱法同时测定非β-内酰胺类药物中β-内酰胺类抗生素头孢美唑（CMZ）和头孢泊肟酯（CPDXPR）污染物的分析方法。所开发的方法在两种化合物的检测限为0.002 ppm时被发现具有灵敏度。CMZ和CPDXPR从奥美沙坦酯（OLM）片剂中的平均回收率分别为96.7%至102.2%和88.9%至94.2%。所开发的方法成功应用于实际生产的OLM片剂中CMZ和CPDXPR污染的验证。
