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

 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，5 μm）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1.4~14 μg·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1.36~20.4 μg·mL^-1内，DEP的线性方程为Y=67.619ρ-30.754（r= 0.999 0）；在1.5~15.5 μg·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。

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

OBJECTIVE To establish a method for the determination the contents of dimethyl phthalate (DMP)， diethyl phthalate (DEP) and dibutyl phthalate (DBP) in lansoprazole enteric-coated capsules. METHODS Based on RP-HPLC/UV， the method used C₁₈ column (4.6 mm×250 mm， 5 μm) for separation， methanol-water (75∶25) as mobile phase for isocratic elution and detection wavelength 230 nm. 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=48.848ρ-2.811 2 (r=0.999 9) in range of 1.4-14 μg·mL^-1， the linear equation of DEP was Y=67.619ρ-30.754(r=0.999 0) in the range of 1.36-20.4 μg·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.