RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE, DICYCLOMINE HCl AND RABEPRAZOLE SODIUM IN PHARMACEUTICAL DOSAGE FORM
Ummekulsum Khan*, Dr. Shailesh V. Luhar and Dr. Sachin B. Narkhede
ABSTRACT
A simple, rapid, economical, precise and accurate RP-HPLC method for simultaneous estimation of Clidinium Bromide, Chlordiazepoxide, Dicyclomine HCl and Rabeprazole Sodium has been developed. Method was studied by using Shimadzu 2010CHT, Chromatographic separation was achieved using ODS C18 RP column (250 mm × 4.6 mm i.d., 5μm) kept at ambient temperature, using a mobile phase consisting a mixture of Phosphate buffer (pH 4.5): Acetonitrile (80:20 v/v) and pH adjusted with 0.5% orthophosphoric acid at a flow rate of 1.0 ml/min. The detection was made at 215 nm. Retention time was 3.12 min, 4.28 min and 6.97 min and 13.29 for Clidinium Bromide, Chlordiazepoxide, Dicyclomine HCl and Rabeprazole Sodium respectively. Linear correlation was obtained between peak area and concentration in the range of 5-15 μg/ml for Clidinium Bromide, 10-30 μg/ml for Chlordiazepoxide, 20-60 μg/ml for Dicyclomine HCl and Rabeprazole Sodium. The percentage recoveries of four drugs Clidinium Bromide, Chlordiazepoxide, Dicyclomine HCl and Rabeprazole Sodium were found to be 100.48- 101.46 %, 98.87-101.75%,98.20-98.80% and 100.94-101.71 % respectively. The % RSD value was less than 2, for intraday and interday precision. It can be successfully used for routine analysis of Clidinium Bromide, Chlordiazepoxide, Dicyclomine HCl and Rabeprazole Sodium in combined solid dosage form without any interference from common excipients and impurity.
Keywords: Clidinium Bromide, Chlordiazepoxide, Dicyclomine HCl, Rabeprazole Sodium, RP-HPLC method development.
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