Abstract
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 (250 × 4.6 mm i.d., 5 μm particle size) column at 25°C. CH3CN-MeOH-NH4OAc 0.1M (30 : 40 : 30, v/v/v) was used as the mobile phase at a flow rate of 1.0 mL min−1 and detector wavelength at 218 nm. 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 2.5–300.0 and 3.0–500.0 μg mL−1 for CDB and CDZ, respectively. The percentage recovery obtained for CDB and CDZ was 100.40–103.38 and 99.98–105.59%, respectively. LOD and LOQ were 0.088 and 0.294 μg mL−1 for CDB and 0.121 and 0.403 μg mL−1 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.
Highlights
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
Several methods have been published for the determination of chlordiazepoxide in biological samples such as voltammetry [26], LC [28], and spectrophotometry [29]
A new reversedphase high-performance liquid chromatographic method is proposed for the simultaneous determination of clidinium bromide and chlordiazepoxide in combined dosage forms
Summary
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. 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]. Few methods for the determination of clidinium bromide and chlordiazepoxide in combined dosage forms including HPLC [5,6,7], derivative spectrophotometry [8, 9], spectrophotometry using multivariate calibration techniques [10], and capillary SFC [11] have been reported. A new reversedphase high-performance liquid chromatographic method is proposed for the simultaneous determination of clidinium bromide and chlordiazepoxide in combined dosage forms
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