反相高效液相色谱法测定兰索拉唑肠溶胶囊中3种邻苯二甲酸酯类增塑剂含量

RP-HPLC/UV Method for the Determination of Three Phthalate Plasticizers in Lansoprazole Enteric-Coated Capsules

目的建立兰索拉唑肠溶胶囊中邻苯二甲酸二甲酯、邻苯二甲酸二乙酯及邻苯二甲酸二丁酯的检定方法。方法基于RP-HPLC/UV,采用C18色谱柱(4.6 mm×250 mm,5μm)进行分离,甲醇-水(75∶25)为流动相进行等度洗脱,检测波长230 nm。结果测定4批兰索拉唑肠溶胶囊中邻苯二甲酸酯的含量。其中在1.4～14μg.mL-1内,邻苯二甲酸二甲酯线性方程为Y=48.848ρ-2.811 2(r=0.999 9);在1.36～20.4μg.mL-1内,DEP的线性方程为Y=67.619ρ-30.754(r=0.999 0);在1.5～15.5μg.mL-1内,邻苯二甲酸二丁酯的线性方程为Y=36.759ρ-4.8507(r=0.999 9)。邻苯二甲酸二甲酯、邻苯二甲酸二乙酯和邻苯二甲酸二丁酯加样回收率分别为91.3%、96.1%和94.7%,其RSD分别为2.9%、4.4%和4.7%。结论本方法操作简单,灵敏度高,具有较强的抗干扰能力,可准确测定兰索拉唑肠溶胶囊中邻苯二甲酸二甲酯、邻苯二甲酸二乙酯和邻苯二甲酸二丁酯的含量。

OBJECTIVE To establish a method for the determination the contents of dimethyl pbthalate （DMP）, diethyl phthalate （DEP） and dibutyl phthalate （DBP） in lansoprazole enteric-coated capsules. METHODS Based on RP-HPLC/UV, the method used Cls column （4. 6 mm ×250 mm, 5μm） for separation, methanol-water （75： 25） as mobile phase for isocratic elution and detection wavelength 230 rim. RESULTS The quantification of diethyl phthalate in four batches of lansoprazole enteric-coated capsules was carried. The concentration and UV peak area with a good linear relationship within the following： the linear equation of DMP was Y =48. 848p -2. 811 2 （ r = 0. 999 9） in range of 1.4 - 14μg·mL-1 , the linear equation of DEP was Y = 67. 619p - 30. 754 （ r = 0. 999 0） in the range of 1.36 - 20. 4μg·mL-1. The linear equation of DBP was Y = 36. 759X - 4. 850 7 （ r = 0. 999 9） in the range of 1.5 - 15.5 μg·mL-1. The sample recovery of DMP, DEP and DBP was 91.3% , 96. 1% and 94. 7%. The RSD of sample recovery was 2. 9% , 4. 4% and 4. 7%. CONCLUSION The method is simple, sensitive and with a strong anti-interference ability. It can determination accurately the contents of DMP, DEP and DBP in lansoprazole enteric-coated capsules.