[關(guān)鍵詞]
[摘要]
目的 將《中國(guó)藥典》項(xiàng)下注射用頭孢噻肟鈉有關(guān)物質(zhì)測(cè)定法的色譜參數(shù)進(jìn)行轉(zhuǎn)化,縮短液相分析時(shí)間,提高檢測(cè)效率。方法 采用Waters Xselect HSS T3 C18柱(100 mm×3 mm,2.5 μm)色譜柱,流動(dòng)相A為0.05 mol· L-1磷酸鹽緩沖液(pH 6.25)-甲醇(86:14),流動(dòng)相B為0.05 mol· L-1磷酸鹽緩沖液(pH 6.25)-甲醇(60:40),先以流動(dòng)相A-流動(dòng)相B (95:5)等度洗脫,待頭孢噻肟鈉洗脫完畢后,立即進(jìn)行線性梯度洗脫(0~0.7 min 95%→75% A,0.7~2.7 min 75% A,2.7~7.8 min 75%→0 A,7.8~9.5 min 100% B,9.5~11.2 min 0→95% A,11.2~14.6 min 95% A),體積流量為0.5 mL·min-1,進(jìn)樣體積為2 μL,檢測(cè)波長(zhǎng)為235 nm。結(jié)果 色譜參數(shù)轉(zhuǎn)化后運(yùn)行時(shí)間從80 min縮短至26 min,方法專屬性、穩(wěn)定性、色譜柱耐用性均良好。結(jié)論 色譜參數(shù)轉(zhuǎn)化后的方法專屬、節(jié)能環(huán)保,可用于注射用頭孢噻肟鈉的有關(guān)物質(zhì)檢測(cè)。
[Key word]
[Abstract]
Objective Transformation of chromatographic parameters in determination of related substances of Cefotaxime Sodium for Injection in chinese pharmacopoeia to shorten the analysis time and improve the efficiency. Methods Waters Xselect HSS T3 C18 (100 mm×3 mm, 2.5 μm) was adopted with 0.05 mol·L-1 phosphate buffer (pH 6.25) -methanol (86:14) as mobile phase A, 0.05 mol· L-1 phosphate buffer (pH 6.25) -methanol (60:40) as mobile phase B. The mobile phase A and B (95:5) were used for constant elution. After the elution of cefotaxime sodium, linear gradient elution was performed immediately (0-0.7 min 95%→75% A, 0.7-2.7 min 75% A, 2.7-7.8 min 75%→0 A, 7.8-9.5 min 100% B, 9.5-11.2 min 0 A→95% A, 11.2-14.6 min 95% A), the flow rate was 0.5 mL·min-1, the injection volume was 2 μL, and the detection wavelength was 235 nm. Results After the conversion of chromatographic parameters, the running time was reduced from 80 min to 26 min, and the specificity, stability and durability of chromatographic column were good. Conclusion The method after the transformation of chromatographic parameters is rapid, exclusive, energy saving and environmental protection. It can be used for the determination of related substances of Cefotaxime Sodium for Injection.
[中圖分類號(hào)]
R917
[基金項(xiàng)目]