Development and validation of RP-HPLC method for the simultaneous estimation of Chordiazepoxide, Clidinium bromide, Dicyclomine hydrochloride and Rabeprazole sodium in bulk and pharmaceutical dosage forms

Abstract

A simple, specific and accurate RP-HPLC method was developed for the simultaneous determination of

Chlordiazepoxide, Clidiniumbromide, Dicyclomine hydrochloride and Rabeprazole sodium in tablet dosage

forms. A waters C18 column (50 mm × 4.6 mm, 5 μm) with mobile phase consisting of acetonitrile and

phosphate buffer 30:70 (v/v) (pH 2.5 adjusted with triethylamine) were used. The flow rate was 1.0 ml/ min and

effluents were monitored at 250 nm. The retention time of Chlordiazepoxide, Clidinium bromide, Dicyclomine

hydrochloride and Rabeprazole sodium in tablet formulation were found to be 4.0 min, 7.3 min, 5.9 min, 6.8

min respectively. The method was validated according to the ICH guidelines for specificity, LOD, LOQ,

precision, accuracy, linearity, ruggedness and robustness. The method showed good reproducibility and

recovery with % RSD less than 2. So the proposed method was found to be simple, specific, precise, accurate

and linear. Hence it can be applied for routine analysis of Chlordiazepoxide, Clidinium Bromide, Dicyclomine

Hydrochloride and Rabeprazole sodium in pharmaceutical combined dosage forms.