Author(s): AravindDoki, KamarapuSK
The study describes method development and subsequent validation of RP-HPLC method for simultaneous estimation of Clidinium bromide (CDB), Chlordiazepoxide (CDZ) and Dicyclomine hydrochloride (DICY) in bulk and combined tablet dosage forms. Chromatographic separation was achieved on a Kromasil C18 (250 mm × 4.6 mm id, 5µm) column using a mobile phase ratio consisting of (40:30:30) Methanol: Acetonitrile: Potassium di hydrogen phosphate buffer (0.05M, PH 4.0 adjusting with 0.5% Ortho phosphoric acid) at flow rate 1.0 ml/min. The detection wavelength is 270 nm. The retention times of Clidinium bromide, Chlordiazepoxide and Dicyclomine hydrochloride were found to be 7.457 min, 4.400 min and 3.397 min respectively. The developed method was validated as per ICH guidelines using the parameters such as accuracy, precision, linearity, LOD, LOQ, ruggedness and robustness. The developed and validated method was successfully used for the quantitative analysis of Clidinium bromide, Chlordiazepoxide and Dicyclomine hydrochloride in bulk and combined tablet dosage forms.