高效液相色谱法测定克林霉素磷酸酯注射液中依地酸二钠含量

HPLC determination of disodium edetate in clindamycin phosphate injection

目的建立高效液相色谱法测定克林霉素磷酸酯注射液中依地酸二钠的含量。方法以Agilent Zorbax SB-_(18)柱(4.6 mm×250 mm,5μm)为色谱柱;以0.006 mol·L^(-1)的四丁基氢氧化铵溶液(用甲酸调节pH至3.5)为流动相A,甲醇为流动相B,梯度洗脱;流速为1.0m L·min^(-1);柱温为30℃;进样量为20μL^(-1)检测波长为254 nm。结果阴性样品溶液对依地酸二钠检测无干扰;依地酸二钠在0.10~6.05μg·mL^(-1)内与峰面积呈良好线性关系(r=0.998);检测限为0.03μg·mL^(-1);回收率(n=3)在98.4%~101.5%。结论本方法专属性好,灵敏度和准确度高,操作简单,适用于克林霉素磷酸酯注射液中依地酸二钠的含量检测。

Objective To develop an HPLC method to determine disodium edetate in clindamycin phosphate injection.Methods HPLC was adopted on an Agilent Zorbax SB-C_(18)column (4.6mm×250 mm,5μm).The mobile phase A was 0.006 mol·L;tetrabutylammonium hydroxide solution (adjust pH to 3.5 with formic acid) and the mobile phase B was methanol at a flow rate of 1.0mL·min^(-1).The column temperature was 30℃and the detection wavelength was 254 nm.Results The negative sample solution did not affect the detection of disodium edetate.The concentration of disodium edetate was linear at 0.10~6.05μg·mL^(-1)(r=0.998),the limit of detection was 0.03μg·mL^(-1),and the recovery (n=3) was at 98.4%~101.5%.Conclusion This method is specific,sensitive and accurate,with simple operation,which is suitable for the detection of disodium edetate in clindamycin phosphate injection.