A sensitive, selective, accurate and precise ultra-high performance liquid chromatography–Tandem mass spectrometry (MS/MS) method was developed and validated for the simultaneous determination of drugs used as eye drops in cataract surgery in aqueous humor. Cataract surgery requires a powerful mydriatic eye drops combination such as cyclopentolate hydrochloride and phenylephrine hydrochloride to dilate the pupil and facilitate eye lens replacement and also requires strong fluoroquinolone antibiotic such as lomefloxacin hydrochloride. The method was performed with positive ion electrospray ionization and the analytes were quantified and monitored on a triple quadrupole mass spectrometer using multiple reaction monitoring scanning mode. Liquid–liquid extraction was used for the purification and preconcentration of analytes from rabbit aqueous humor matrix. Chromatographic elution was performed using an Phenomenex Luna® C18 (150 mm × 2.1 mm, 1.6 μm) column and moxifloxacin hydrochloride as internal standard with a mobile phase consisting of methanol:water:formic acid (70:29:1, by volume) at flow rate of 0.2 mL/min. Satisfactory results regarding linearity, recovery, stability, accuracy and precision of the analytes were obtained. Full validation of the procedure was performed according to the US Food and Drug Administration guidance for industry: bioanalytical method validation and European Medicines Agency (EMA) guideline on bioanalytical method validation.

中文翻译：

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经验证的液相色谱-串联质谱法同时测定兔水性幽默白内障手术中使用的某些药物。

开发了灵敏，选择性，准确和精确的超高效液相色谱-串联质谱（MS / MS）方法，并验证了该方法可同时测定房水白内障手术中用作滴眼剂的药物。白内障手术需要强效的散瞳滴眼剂组合（例如盐酸环戊酯和盐酸去氧肾上腺素）来扩张瞳孔并促进晶状体更换，还需要强效的氟喹诺酮类抗生素（例如盐酸洛美沙星）。该方法采用正离子电喷雾电离进行，对分析物进行定量，并使用多重反应监控扫描模式在三重四极杆质谱仪上进行监控。液液萃取用于从兔房水基质中纯化和预浓缩分析物。使用PhenomenexLuna®C18（150 mm×2.1 mm，1.6μm）色谱柱和盐酸莫西沙星作为内标进行色谱洗脱，流动相由甲醇：水：甲酸（体积比为70：29：1）组成流速为0.2 mL / min。获得了有关分析物线性，回收率，稳定性，准确性和精密度的令人满意的结果。根据美国食品和药物管理局针对行业的指南进行了完全验证：生物分析方法验证和欧洲药品管理局（EMA）关于生物分析方法验证的指南。6μm）色谱柱和莫西沙星盐酸盐作为内标，流动相由甲醇：水：甲酸（体积比为70：29：1）组成，流速为0.2 mL / min。获得了有关分析物线性，回收率，稳定性，准确性和精密度的令人满意的结果。根据美国食品和药物管理局针对行业的指南进行了完全验证：生物分析方法验证和欧洲药品管理局（EMA）关于生物分析方法验证的指南。6μm）色谱柱和莫西沙星盐酸盐作为内标，流动相由甲醇：水：甲酸（体积比为70：29：1）组成，流速为0.2 mL / min。获得了有关分析物线性，回收率，稳定性，准确性和精密度的令人满意的结果。根据美国食品和药物管理局针对行业的指南进行了完全验证：生物分析方法验证和欧洲药品管理局（EMA）关于生物分析方法验证的指南。