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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,5μm)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 m L·min~(-1),柱温35℃,检测波长225 nm,进样量10μL。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·m L~(-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。
OBJECTIVE To establish a method for isomeric analysis of bepotastine benzenesulfonate eye drops and to investigate the isomer stability of bepotastine benzenesulfonate in bepotastine benzenesulfonate eye drops. Methods Chromatographic separation was performed on a ULTRON ES-CD (6.0 mm × 150 mm, 5 μm) column using a mobile phase of 0.02 mol·L -1 KH 2 PO 4 at 75:25 with a flow rate of 0.8 m L · min ~ (-1), column temperature 35 ℃, detection wavelength 225 nm, injection volume 10μL. Results The detection limit of benaustin besylate R-isomer was 12 ng at a wavelength of 225 nm and the limit of quantification was 48 ng. The linearity was good at 0.01 ~ 0.1 mg · m L -1, High, medium and low concentrations of 3 repeatability good. Conclusion The method is accurate and reliable with good stability. It can be used for the isomer analysis of bepotastine besilate and the stability of isomers in bepotastine benzenesulfonate eye drops.