摘要
目的：建立注射液A中测定枸橼酸根和醋酸根含量的HPLC方法。方法：用磺酸基阴离子交换树脂为填充剂；以0．025mol／L硫酸溶液（取硫酸1．5ml，加水定容至1000ml，摇匀）为流动相；检测波长210nm；流速1．0ml／min；柱温30℃。结果：枸橼酸根在0．294—0．882mg，fnl范围内线性关系良好，r=0．9998（n=5），平均回收率100．5％，日内精密度RSD〈1％；醋酸根在1．7—5．1mg，fnl范围内线性关系良好，r=0．9999（n=5），平均回收率为100．0％，日内精密度RSD〈1％。结论：HPLC法测定醋酸根和枸橼酸根选择性强，方便快捷，准确，可用于常规制剂分析。
Object： To estabhsh an HPLC method to determine the content of acetate sodium and citrate sodium in Injection A. Methods： The HPLC separation was performed on a Hamilton PRP - X300 ion exclusion HPLC column （250 mm ×4. 1mm, 7μm） with mobile phase of 0.025 mol/L sulphuric acid at a flow rate of 1.0 ml/min. The detection wavelength was 210 nm. The column temperature was 30℃. Results： The linear correlation of sodium citrate was observed over a range of 0.294-0.882 mg/ml, r =0.999 8 （ n = 5）. The average recovery was 100.5% and intra- day RSD was less than 1% ; The linear correlation of sodium acetate was observed over a range of 1.7-5.1 mg/ml, r = 0.999 9 （ n = 5）. The average recovery was 100.0% with intra - day RSD less than 1% respectively. Conclusion： This method is accurate, simple and rapid and can be used for the analysis of acetate and citrate in Injection A.
出处
《天津药学》
2006年第5期8-9,共2页
Tianjin Pharmacy
