目的 建立苯磺酸贝他斯汀滴眼液中的异构体分析方法，并用此方法考察苯磺酸贝他斯汀滴眼液中苯磺酸贝他斯汀的异构体稳定性。方法 采用ULTRON ES-CD(6.0 mm×150 mm，5 μm)手性柱，流动相为0.02 mol·L-1磷酸二氢钾-乙腈(75∶25)，流速0.8 mL·min-1，柱温35 ℃，检测波长225 nm，进样量10 μL。结果 在225 nm检测波长下，苯磺酸贝他斯汀R-异构体检测限为12 ng，定量限为48 ng;在0.01~0.1 mg·mL-1内线性关系良好，高、中、低3个浓度重复性良好。结论 本方法准确可靠，稳定性好，可以用于苯磺酸贝他斯汀的异构体分析，并对苯磺酸贝他斯汀滴眼液中异构体稳定性进行考察。
Abstract
OBJECTIVE To establish a method for isomer analysis of bepotastine besilate eye drops and test the stability of isomer in the preparation. METHODS The analysis was performed on an ULTRON ES-CD chiral column (6.0 mm×150 mm,5 μm). The mobile phase was 0.02 mol·L-1 potassium phosphate monobasic-acetonitrile(75∶25) at the flow of 0.8 mL·min-1. The column temperature was maintained at 35 ℃ and the detection wavelength was set at 225 nm. The injection volume was 10 μL. RESULTS The limit of detection and limit of quantification of bepotastine besilate R-isomer were 12 and 48 ng, respectively. The linear range of bepotastine besilate R-isomer was 0.01-0.1 mg·mL-1 and the repeatability was good at high, medium and low concentrations. CONCLUSION The method is simple and accurate, which can be used for isomer separation of bepotastine besilate and testing the stability of isomer in bepotastine besilate eye drops.
关键词
苯磺酸贝他斯汀 /
高效液相色谱法 /
异构体分离 /
稳定性。
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Key words
bepotastine besilate /
HPLC /
isomer separation /
stability
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中图分类号：
R917
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参考文献
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