【摘要】：目的建立適用于注射用頭孢硫脒有關物質檢查的HPLC法。方法采用_(1 8)色譜柱(Kromasil 100-5C_(1 8),250mm×4.6mm,5μm),以磷酸鹽緩沖液(取無水磷酸氫二鈉2.76g,檸檬酸1.29g,加水溶解并稀釋成1000m L)-乙腈(86:14)為流動相;檢測波長為254nm。結果自身對照溶液在1~108μg/m L范圍內,溶液濃度和峰面積線性關系良好(r=0.9999),頭孢硫脒最低檢出限為2ng。結論本方法操作簡便,專屬性強,結果可靠,可用于注射用頭孢硫脒有關物質的測定,已應用于中國藥典2015年版注射用頭孢硫脒質量標準。
[Abstract]:Objective to establish a HPLC method for the determination of cefathiamidine for injection. Methods Kromasil 100-5C18 column and 250mm 脳 4.6 mm ~ 5 渭 m), were used in phosphate buffer solution (2.76 g anhydrous disodium hydrogen phosphate, 1.29 g citric acid). The mobile phase was dissolved in water and diluted to 1000ml) -acetonitrile (86:14). The detection wavelength is 254 nm. Results the linear relationship between the concentration and the peak area of the autocontrol solution was good in the range of 1 ~ 108 渭 g / mL (r = 0.9999), and the minimum detection limit of cefathiamidine was 2 ng / mL. Conclusion the method is simple, specific and reliable. It can be used for the determination of cefathiamidine for injection. It has been applied to the quality standard of cefathiamidine for injection in Chinese Pharmacopoeia 2015.
【作者單位】： 廣東省藥品檢驗所;
【基金】：廣東省醫(yī)學科學技術研究基金(No.2015117103428214)
【分類號】：R927;O657.72
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本文編號：2301194