高效液相色谱法同时测定复方葡萄糖酸钙口服溶液中2组分的含量

目的:建立以高效液相色谱法同时测定复方葡萄糖酸钙口服溶液中乳酸钙和葡萄糖酸钙含量的方法。方法:色谱柱为C18,流动相为0.025mol/LNaH2PO4(pH=2.50),检测波长为210nm,流速为1.0ml/min,柱温为25℃,进样量为20μl。结果:乳酸、葡萄糖酸检测浓度分别在0.719～46.040(r=0.9999)、0.315～20.160(r=0.9999)mmol/L范围内线性关系良好;平均加样回收率分别为99.0%(RSD=1.65%)、100.5%(RSD=1.36%)。结论:本方法快速、简便、准确,且可不经分离直接同时测定本品中乳酸钙和葡萄糖酸钙的含量,可用于复方葡萄糖酸钙口服溶液的质量控制。

Simultaneous Determination of 2 Components in Compound Calcium Gluconate Oral Solution by HPLC

OBJECTIVE:To establish HPLC method for the simultaneous determination of calcium lactate and calcium gluconate in compound calcium gluconate oral solution.METHODS:The test was performed on C 18 column with column temˉperature at25℃;the mobile phase was composed of0.025mol/L NaH 2 PO 4 (pH=2.50)with a flow rate of1.0ml/min and sam ple size of20μl;the detection wavelength was210nm.RESULTS:The calibration curves were linear over the range of0.719～46.040mmol/L(r=0.9999)for lactic acid and0.315～20.160mmol/L(r=0.9999)for gluconic acid.The average recovery rates of which were99.0%(RSD=1.65%)and100.5%(RSD=1.36%),respectively.CONCLUSION:This method is fast,simple,accurate,and it can be employed directly without isolation to determine the content of calcium lactate and calcium gluˉconate simultaneously and to control the quality of compound calcium gluconate oral solution as well.