Determination of N-acetylcysteine in the presence of ciprofloxacin or levofloxacin in microparticulate dry powder inhalers

Authors : Yağmur Akdağ ÇAYLI, Selma ŞAHİN, Emirhan NEMUTLU, Levent ÖNER

Pages : 846-856

View : 15 | Download : 6

Publication Date : 0000-00-00

Article Type : Research Paper

Abstract :A fast and easy method was validated for simultaneous determination of ciprofloxacin hydrochloride monohydrate insert ignore into journalissuearticles values(CP);, levofloxacin hemihydrate insert ignore into journalissuearticles values(LV);, and N-acetylcysteine insert ignore into journalissuearticles values(NAC); in samples. The analysis was performed on a C$_{18}$ column insert ignore into journalissuearticles values(250 x 4.6 mm, 5 μm); insert ignore into journalissuearticles values(Inertsil ODS-3V); using an isocratic elution method with a mobile phase composed of 25 mM KH$_{2}$PO$_{4}$ insert ignore into journalissuearticles values(pH 3.0); and methanol insert ignore into journalissuearticles values(72:28, v/v); at a flow rate of 1 mL/min. UV detection was performed at 214 nm for NAC and 293 nm for CP and LV. The method was validated for linearity, accuracy, precision insert ignore into journalissuearticles values(repeatability and reproducibility);, specificity, sensitivity, and stability. The calibration study using several media demonstrated that the calibration curves were linear for all compounds in all media insert ignore into journalissuearticles values(R$^{2}$ > 0.9993);. The limit of detection was 0.098 μg/mL for CP, 0.049 μg/mL for LV, and 0.487 μg/mL for NAC. The limit of quantification was 0.328 μg/mL for CP, 0.165 μg/mL for LV, and 1.624 μg/mL for NAC. Precision and accuracy values of the method fulfilled the required limits. All these outcomes demonstrate that the validated HPLC method is appropriate for simultaneous analysis of CP, LV, and NAC in samples for content uniformity of dry powder inhaler and permeability studies.
Keywords : Ciprofloxacin, levofloxacin, N acetylcysteine, HPLC, validation, dry powder inhaler