DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF CLIDINIUM BROMIDE, RABEPRAZOLE, CHLORDIAZEPOXIDE AND DICYCLOMINE HYDROCHLORIDE

Abstract

Clidinium bromide, rabeprazole sodium, chlordiazepoxide and dicyclomine hydrochloride(COLIWIN-R) drug combinations are used for the treatment of gastric acidity, anxiety, intestinal ulcers, abdominal cramps, irritable bowel syndrome and abdominal pain. A high performance liquid chromatographic method has been developed and validated for the simultaneous determination of clidinium bromide, rabeprazole sodium, chlordiazepoxide and dicyclomine hydrochloride in capsules dosage forms using WATERS C18 column (50 mm × 4.6 mm, 5 µm) with mobile phase consisting of methanol, acetonitrile and phosphate buffer 40:30:30 (V/V) (0.05M, pH 4.0 adjusting with 0.5% ortho phosphoric acid) at a flow rate of 1.0 mL/ min monitoring the effluents at 220 nm. The retention times of clidinium bromide, rabeprazole sodium, chlordiazepoxide and dicyclomine hydrochloride in capsule formulation were found to be 2.9 min, 3.5 min, 4.7 min, and 8.0 min, respectively. The method was validated according to the ICH guidelines for specificity, LOD, LOQ, precision, accuracy, linearity, ruggedness and robustness. The method show good reproducibility and recovery with % RSD less than 2. The proposed method was found to be simple, specific, precise, accurate and linear. Hence, it can be applied for routine analysis of clidinium bromide, rabeprazole sodium, chlordiazepoxide and dicyclomine hydrochloride in pharmaceutical combined dosage forms.