School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing 211816, China.
Jiangsu Center for Safety Evaluation of Drugs, Jiangsu Provincial Institute of Materia Medica, Nanjing 210009, China.
Molecules. 2022 Nov 16;27(22):7934. doi: 10.3390/molecules27227934.
Treatment of ocular infection involves pharmacotherapy with steroids and antibiotic drops, such as moxifloxacin hydrochloride (MFH) and dexamethasone sodium phosphate (DSP). To characterize the pharmacokinetics of these two compounds, we performed and validated a liquid chromatography-mass spectrometry (LC-MS/MS) method to quantify them in rabbit ocular tissues and plasma. We used protein precipitation to extract the compounds. The analyte and internal standard (IS) were separated using a Shim-pack Scepter C18 column. The mobile phase was composed of 0.1% formic acid water (A) and methanol (B). MFH and DSP were detected using positive ion electrostatic ionization (ESI) in multiple reaction monitoring mode (MRM). The calibration curves for both compounds showed good linearity over concentrations ranging from 0.5 to 200 ng/mL in rabbit ocular tissues and plasma. The lower limit of quantification for both MFH and DSP was 0.5 ng/mL. We validated this method for selectivity, linearity (r2 > 0.99), precision, accuracy, matrix effects, and stability. Thus, we used this method to assess the pharmacokinetic (PK) characteristics of MFH and DSP in rabbit ocular tissues and plasma after single doses. Our results indicate that this method can be used for the simultaneous analysis of moxifloxacin hydrochloride and dexamethasone sodium phosphate in clinical samples.
眼部感染的治疗包括使用类固醇和抗生素滴眼剂进行药物治疗，如盐酸莫西沙星（MFH）和磷酸二氢钠地塞米松（DSP）。为了描述这两种化合物的药代动力学特征，我们建立并验证了一种液相色谱-质谱联用（LC-MS/MS）方法，用于定量检测兔眼组织和血浆中的这两种化合物。我们使用蛋白沉淀法提取这些化合物。使用 Shim-pack Scepter C18 柱分离分析物和内标（IS）。流动相由 0.1%甲酸水（A）和甲醇（B）组成。MFH 和 DSP 通过正离子静电电离（ESI）在多重反应监测模式（MRM）下进行检测。两种化合物的校准曲线在兔眼组织和血浆中浓度为 0.5 至 200ng/mL 范围内均具有良好的线性关系。MFH 和 DSP 的定量下限均为 0.5ng/mL。我们验证了该方法的选择性、线性（r2>0.99）、精密度、准确度、基质效应和稳定性。因此，我们使用该方法评估了单次给药后 MFH 和 DSP 在兔眼组织和血浆中的药代动力学（PK）特征。我们的结果表明，该方法可用于临床样本中盐酸莫西沙星和磷酸二氢钠地塞米松的同时分析。
