LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids.
LC-MS/MS method for simultaneous quantification of dexamethasone and tobramycin in rabbit ocular biofluids.
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DOI：
10.1016/j.jchromb.2021.122610
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发表时间：
2021-04-30
期刊：
影响因子：
--
通讯作者：
Xu Q
中科院分区：
文献类型：
--
作者：
Meng T;Kosmider L;Chai G;Moothedathu Raynold AA;Pearcy AC;Qin B;Wang Y;Lu X;Halquist MS;Xu Q
Tobradex®软膏配方的复杂性(地塞米松0.1wt%和妥布霉素0.3wt%)和人体房水药代动力学(PK)研究的高昂成本阻碍了仿制药公司推进与Tobradex®类似的产品开发。体外药物释放试验将是区分同时含有地塞米松和TOB的仿制制剂的一种替代方法，其结果应与体内眼部PK研究相关联，以便进一步评估。为便于眼部活体PK的研究，建立了一种灵敏、快速、特异的高效液相色谱-串联质谱仪(LC-MS/MS)同时测定兔眼泪液、房水和角膜基质中地塞米松(DEX)和妥布霉素(TOB)的方法。定量下限(LLOQ)DEX为1.5 ng/ml，TOB为3 ng/ml，具有良好的精密度和准确度。批内和批间精密度均在±15%以内，所有质控的准确度均在85%~115%之间。这一新方法被成功地应用于局部使用Tobradex®软膏后DEX和TOB在兔泪液中的中试药代动力学分析。
The complexity of Tobradex® ointment formulation (dexamethasone 0.1 wt% and tobramycin 0.3 wt%) and the high cost of pharmacokinetic (PK) studies in human aqueous humor prevent generic drug companies from moving forward with a Tobradex®-equivalent product development. The in vitro drug release test would be an alternative approach for differentiating the generic formulations containing both DEX and TOB, and the results should be correlated with the in vivo ocular PK studies for further evaluation. To facilitate the in vivo ocular PK studies, a sensitive, rapid and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that can simultaneously quantify both dexamethasone (DEX) and tobramycin (TOB) in rabbit ocular matrices including tear, aqueous humor and cornea was established and validated. The lower limit of quantification (LLOQ) was 1.5 ng/ml for DEX and 3 ng/ml for TOB with good precision and accuracy. Both intra- and inter-batch precisions were within ±15%, and the accuracy for all QCs was within the range of 85% – 115%. This new method was successfully applied for a pilot pharmacokinetic analysis of DEX and TOB in rabbit tears after topical administration of Tobradex® ointment.
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