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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 of dimethyl phthalate, diethyl phthalate and dibutyl phthalate in lansoprazole enteric-coated capsules. The method was based on RP-HPLC / UV and was separated on a C18 column (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of methanol and water (75:25). The detection wavelength was 230 nm. Results The contents of phthalates in 4 batches of lansoprazole enteric-coated capsules were determined. The linear equation of dimethyl phthalate was Y = 48.848ρ-2.811 2 (r = 0.999 9) in 1.4 ~ 14μg.mL-1. The linear equation of DEP in 1.36 ~ 20.4μg.mL-1 The linear equation for dibutyl phthalate was Y = 36.759ρ-4.8507 (r = 0.999 9) for Y = 67.619ρ-30.754 (r = 0.999 0). The recoveries of dimethyl phthalate, diethyl phthalate and dibutyl phthalate were 91.3%, 96.1% and 94.7% respectively, with RSDs of 2.9%, 4.4% and 4.7% . Conclusion The method is simple, sensitive, and has strong anti-interference ability. It can accurately determine the concentration of diethyl phthalate, diethyl phthalate and dibutyl phthalate in lansoprazole enteric- Ester content.