title: Stability-indicating High-performance Liquid Chromatography Method for Simultaneous Determination of Aminophylline and Chlorpheniramine Maleate in Pharmaceutical Formulations.
abstract: The present work deals with the development and validation of method for simultaneous determination of antihistaminic drugs in pharmaceutical formulations. A precise, specific and accurate reverse phase-high-performance liquid chromatography method for the simultaneous measurement of aminophylline and chlorpheniramine maleate was developed. The separation of drugs was achieved on C-18 (5 μm, 250×4.6 mm) high-performance liquid chromatography column. The runtime for analysis was 10 min. Mobile phase is mixture containing dilute H2SO4:methanol (60:40% v/v) with flow rate adjusted at 1.5 ml/min. The detection of components was performed at a wavelength of 264 nm. Retention times of aminophylline and chlorphinramine maleate were found to be 2.00 and 3.25 min, respectively. Linearity was found in the range of 16-24 μg/ml for chlorpheniramine maleate and 102.4-153.6 μg/ml for aminophylline with a correlation coefficient of 0.9998 and 0.9996, respectively. High peak purity index of 99.99% indicated the complete separation of analytes in the presence of degradation products is justification of method stability. Linearity, accuracy, specificity, precision and robustness studies were performed for method validation.
authors.affiliation: Government College of Science, Wahdat Road, Lahore, Pakistan.
authors.forename: A
authors.initials: A
authors.lastname: Ali
authors.affiliation: Institute of Chemistry, University of the Punjab, New Campus, Lahore, Pakistan.
authors.forename: M
authors.initials: M
authors.lastname: Ahmed
authors.affiliation: Institute of Chemistry, University of the Punjab, New Campus, Lahore, Pakistan.
authors.forename: T
authors.initials: T
authors.lastname: Mahmud
authors.affiliation: Institute of Chemistry, University of the Punjab, New Campus, Lahore, Pakistan.
authors.forename: M A
authors.initials: MA
authors.lastname: Qadir
authors.affiliation: Schazoo Pharmaceutical Laboratories, Kalalwala Stop, 20 Km Lahore Jaranwala Road, District Sheikhupura, Lahore, Pakistan.
authors.forename: K
authors.initials: K
authors.lastname: Nadeem
authors.affiliation: CCL Pharmaceuticals, 65 Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore, Pakistan.
authors.forename: A
authors.initials: A
authors.lastname: Saleem
keywords: Antihistaminic drugs; ICH; RP-HPLC; degradation products; validations