AlQuadeib Bushra T, Aleanizy Fadilah S, Alqahtani Fulwah Y, Alshammari Rehab A, Aldarwesh Amal, Alsarra Ibrahim
Department of Pharmaceutics, College of Pharmacy, King Saud University, Saudi Arabia, P.O. Box 84428, Riyadh 11671, Saudi Arabia.
Department of Optometry, College of Applied Medical Sciences, King Saud University, P.O. 11671, Riyadh 11671, Saudi Arabia.
Saudi Pharm J. 2023 Apr;31(4):547-553. doi: 10.1016/j.jsps.2023.02.007. Epub 2023 Feb 25.
Ruboxistaurin (RBX) used to treat retinopathy in diabetic patients which caused by microvascular damage and leakage which contributes to visual loss. There are no published studies on the use of liquid chromatography-tandem mass spectrometry for development and validation of a simple, sensitive, and accurate method for measuring RBX in rat plasma.
Chromatographic separation of RBX was achieved using ultra-performance liquid chromatography. Multiple-reaction monitoring quantification used RBX [M + H] + ion at / 469.18 and daughter ions at / 84, 58.12, and 98.10. Atorvastatin was used as internal standard (IS), has a single daughter ion, and was identified using / 559.6 → 249.9. Validation of the liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for RBX in rat plasma for linearity (greater than0.997) was carried out at 25-1000 ng/mL.
In rat plasma, the accuracy was within 3.4%, and the intra- and inter-day precision was within 11.8%. Stability, recovery, and matrix effect were all within acceptable limits. The drug retention time (0.85 ± 0.03 min) was remarkably short.
The method developed in the current study is suitable to quantify RBX in plasma or bulk doses.
鲁比前列酮（RBX）用于治疗糖尿病患者因微血管损伤和渗漏导致的视网膜病变，这种损伤和渗漏会导致视力丧失。目前尚无关于使用液相色谱 - 串联质谱法开发和验证一种简单、灵敏且准确的大鼠血浆中RBX测定方法的公开研究。
使用超高效液相色谱实现RBX的色谱分离。多反应监测定量采用RBX [M + H]+离子，质荷比为469.18，子离子质荷比为84、58.12和98.10。阿托伐他汀用作内标（IS），有一个单一子离子，通过质荷比559.6→249.9进行鉴定。在25 - 1000 ng/mL范围内对大鼠血浆中RBX的液相色谱 - 串联质谱（LC - MS/MS）方法进行线性验证（大于0.997）。
在大鼠血浆中，准确度在3.4%以内，日内和日间精密度在11.8%以内。稳定性、回收率和基质效应均在可接受范围内。药物保留时间（0.85±0.03分钟）非常短。
本研究中开发的方法适用于定量血浆或大剂量中的RBX。
