Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study

Authors : Emrah DURAL, Sema Tülay KÖZ, Süleyman KÖZ

Pages : 16-25

View : 33 | Download : 12

Publication Date : 2021-04-30

Article Type : Research Paper

Abstract :Background and Aims: It has been observed that the combined treatment of esomeprazole and pirfenidone provides increased efficacy in the treatment of pulmonary fibrosis disease, recently. The aim of this study is to develop a simple, sensitive, and reliable high-performance liquid chromatography method to be used in drug monitoring to increase the effectiveness of esomeprazole and pirfenidone in treatment and to reduce their adverse effects. Methods: Separation was conducted with a C18 reverse-phase column insert ignore into journalissuearticles values(4.6 mm x 250 mm, 5 μm); used as a mobile phase prepared with the phosphate buffer insert ignore into journalissuearticles values(10 mM KH2PO4 and 10 mM K2HPO4); and acetonitrile insert ignore into journalissuearticles values(60:40, v/v); by an isocratic flow insert ignore into journalissuearticles values(1 mL/min);. Mobile phase pH was adjusted to 3.0. Ultraviolet detection was accomplished at 305 nm. The column oven was held at 35°C to ensure an efficient analytical separation. Results: Analytical recovery of esomeprazole was between 92.43 and 105.36% and for pirfenidone it was found between 89.56 and 104.32%. Accuracy values of esomeprazole and pirfenidone were determined between insert ignore into journalissuearticles values(-2.90); – 4.22 and insert ignore into journalissuearticles values(-4.45); – 5.78, respectively. Precision insert ignore into journalissuearticles values(RSD%); was ≤7.89. The quantification limit was determined as 0.58 and 0.36 ng/mL. Plasma esomeprazole and pirfenidone levels were found as 0.87-8296.87 ng/mL insert ignore into journalissuearticles values(612.99±2212.20, mean ± standard deviation); and 0.45-238.60 ng/mL insert ignore into journalissuearticles values(61.44±76.35, mean ± standard deviation);, respectively. Conclusion: Unexpectedly high RSD values were observed in both plasma insert ignore into journalissuearticles values(360.88%); and dose-rated results insert ignore into journalissuearticles values(89.61%); of esomeprazole, and pirfenidone were thought to be related to individual metabolism differences.
Keywords : Esomeprazole, pirfenidone, rat plasma, method validation, HPLC UV

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