Development and validation of a simple HPLC assay method for ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate in syrup form
Hande Kazak Sarılmışer, N. Orçun Özçelik, Banu Özkırım Arslan, Mine Gökalp, Arzu Ustaoğlu, Udaya Kumar Dude and Zdravka Knezevic
J. Chem. Metrol. (2017), 11:2 ; 61-67
Abdi Ibrahim Pharmaceutical Company, Research and Development Center, Esenyurt, Istanbul, Türkiye
Abstract: A simple, rapid, sensitive, robust, stability-indicating HPLC analytical protocol was developed and validated for the analysis of Ibuprofen, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate in syrup formulation. The samples were assayed by the Waters HPLC instrument using a GL Sciences Inertsil ODS4 column (250 mm length × 4.6 mm width; 5 μm particle size) under timed gradient conditions. The flow rate of the mobile phase was 1.2 mL/min and the eluent was monitored at 214 nm. The method was validated by determining precision, linearity and range, specificity, accuracy and recovery, and robustness. The developed chromatographic method proved to be simple, precise, accurate, robust and reproducible. Moreover, the samples showed stability at room temperature over a period of 55 h. Thus, this method would be employed for routine simultaneous quantification of Ibuprofen, Pseudoephedrine Hydrochloride, and Chlorpheniramine Maleate in Syrup formulation.
Keywords: HPLC; ibuprofen; pseudoephedrine hydrochloride; chlorpheniramine maleate; method validation © 2017 ACG Publications. All rights reserved.