Stability-indicating RP-HPLC method for the simultaneous determination of clidinium bromide and chlordiazepoxidein pharmaceutical formulations

摘要

A novel stability indicating RP-HPLC method was developed and validated for simultaneous determination of clidinium bromide and chlordiaz-epoxide in pharmaceutical dosage form. Kromasil RP- C18 (250 mm x 4.6 mm, 5 urn) column was used for separation of the components. A mobile phase comprising of a mixture of methanol: acetonitrile: water in the ratio 40:50:10 (v/v) was degassed under ultrasonication before use. The flow rate was maintained at 1.0 mL/min and the effluent was monitored at 228 nm. The retention times of clidinium bromide and chlordiazepoxide were found to be 5.56 min and 3.19 min respectively. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection, limit of quantitation. Linearity was found to be in the range of 2.5-15 μg/mL for clidinium bromide and 5-30 μg/mL for chlordiazepoxide respectively. The method was successfully applied to separate and study the stability of the drugs. The results indicated that the drugs are stable at the sunlight, peroxide, UV and aqueous condition and sensitive in alkali and acidic conditions than others. The method was also successfully applied for the analysis of formulations in marketed samples.