摘要
目的建立测定替硝唑氯化钠注射液中乙二胺四乙酸二钠含量的高效液相色谱法。方法色谱柱为Agilent C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-缓冲液(10%四丁基氢氧化铵溶液6 mL,加水稀释至200 mL,以磷酸调节pH至6.5)-水(20∶20∶60),检测波长为254 nm,流速为1.0 mL/min,柱温为30℃,进样量为20μL。结果乙二胺四乙酸二钠进样量在0.1~2.0μg范围内与峰面积线性关系良好(r=0.999 8),平均回收率为100.37%,RSD为0.78%(n=9)。结论该方法简便、准确、灵敏度高,重复性好,可用于替硝唑氯化钠注射液中乙二胺四乙酸二钠的含量测定。
Objective To establish the high performance liquid chromatography（HPLC）method for determining the content of disodium edetate in Tinidazole and Sodium Chloride Injection. Methods The chromatographic column was the Agilent CIs column（150 mm~ 4. 6 mm, 5 I^m） with acetonitrile -buffer solution（ 10% tetrabutylammonium solution 6 mL, adding water for diluting to 200 mL, adjusting pH to 6.5 with phosphoric acid）-water（20：20：60） as the mobile phase. The detection wavelength was 254nm and the flow rate was 1.0 mL/min. The column temperature was 30 ~C. The injection volume was 20 IxL. Results The calibration curves of disodium edetate were linear in the range of 0. 1-2. 0 Ixg（r=0.999 8）. The average recovery rate was 100. 37%, RSD=O. 78% （n=9）. Conclusion This method is simple and accurate with high sensitivity and good reproducibility, which can be used for the content determination of disodium edetatein in Tinidazole and Soudiun Chloride Injection.
出处
《中国药业》
CAS
2013年第24期37-38,共2页
China Pharmaceuticals
