%0 Journal Article
%T Simultaneous Determination of Clidinium Bromide and Chlordiazepoxide in Combined Dosage Forms by High-Performance Liquid Chromatography
%A Safwan Ashour
%A Nuha Kattan
%J Journal of Pharmaceutics
%D 2013
%I Hindawi Publishing Corporation
%R 10.1155/2013/417682
%X A sensitive and precise RP-HPLC method has been developed for the simultaneous estimation of clidinium bromide (CDB) and chlordiazepoxide (CDZ) in pure and pharmaceutical formulations. The separation was achieved on a Nucleodur C8 ( ˋmm i.d., 5ˋ米m particle size) column at 25∼C. CH3CN-MeOH-NH4OAc 0.1M (30ˋ:ˋ40ˋ:ˋ30, v/v/v) was used as the mobile phase at a flow rate of 1.0ˋmLˋminˋ1 and detector wavelength at 218ˋnm. Almotriptan (ALT) was used as internal standard. The validation of the proposed method was carried out for linearity, accuracy, precision, LOD, LOQ, and robustness. The method showed good linearity in the ranges of 2.5每300.0 and 3.0每500.0ˋ米gˋmLˋ1 for CDB and CDZ, respectively. The percentage recovery obtained for CDB and CDZ was 100.40每103.38 and 99.98每105.59%, respectively. LOD and LOQ were 0.088 and 0.294ˋ米gˋmLˋ1 for CDB and 0.121 and 0.403ˋ米gˋmLˋ1 for CDZ, respectively. The proposed method was successfully applied to the determination of CDB and CDZ in combined dosage forms and the results tallied well with the label claim. 1. Introduction Chlordiazepoxide (7-chloro-N-methyl-5-phenyl-3H-1, 4-benzodiazepine-2-amina-4-oxide) is used as an anxiolytic, sedative, hypnotic, anticonvulsant, and/or skeletal muscle relaxant. The drug may inhibit monosynaptic and polysynaptic reflexes by acting as an inhibitory neuronal transmitter or by blocking excitatory synaptic transmission. The drug may also directly depress motor nerve and muscle function [1, 2]. Clidinium bromide (3-[(hydroxy-diphenylacetyl)-oxy]-1-methyl-1-azoniabicylo-[2.2.2] octane bromide is an anticholinergic drug which may help symptoms of cramping and abdominal stomach pain by decreasing stomach acid and slowing the intestines. It is commonly prescribed in combination with chlordiazepoxide by the name of clidinium-c [3]. The United States Pharmacopeia (USP) stated the nonaqueous titration method for the assay of clidinium bromide and chlordiazepoxide [4]. Few methods for the determination of clidinium bromide and chlordiazepoxide in combined dosage forms including HPLC [5每7], derivative spectrophotometry [8, 9], spectrophotometry using multivariate calibration techniques [10], and capillary SFC [11] have been reported. Literature survey revealed that some analytical methods have been used for the individual estimation of clidinium bromide and chlordiazepoxide. Capillary electrophoresis [12] and kinetic spectrophotometric [13] methods for clidinium bromide have been described. Chlordiazepoxide has been determined either alone or with other compounds in pharmaceutical formulations using
%U http://www.hindawi.com/journals/jphar/2013/417682/