European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR CONTENT UNIFORMITY TEST OF CLIDINIUM BROMIDE CHLORDIAZEPOXIDE AND DICYCLOMINE HCl IN COMBINED DOSAGE FORM

Nisha R. Patil*, Shailesh V. Luhar and Sachin B. Narkhede

ABSTRACT

The aim of the present work was to develop simple, shorter and effective RP-HPLC method with UV detection (209nm) and subsequent validation for the content uniformity determination of Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl in marketed tablet samples. The method uses isocratic mobile phase of phosphate buffer (pH 5) and methanol 60:40 compositions on reverse phase Shimadzu LC 2010 CHT C18 column. The linearity range of Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl was Linearity observed for 5-15 μg/ml, 10-30μg/ml and 20-60μg/ml. percentage of label claim established with 0.9999 correlation, Retention time of Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl was found to be 4.200, 3.420, 11.570 min. respectively and The percentage recoveries Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl obtained for were found to be in range of 99.81-100.47, 99.47-100.89, 100.23-100.71 respectively. different brands marketed samples were successfully analysed for content uniformity and compared the results with the USP and other guidelines for acceptance criteria. The developed method was found precise, linear, rugged and robust for validated parameters. The method can be used for assay and the content uniformity determination of Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl in its tablet dosage form.

Keywords: Clidinium bromide, Chlordiazepoxide and Dicyclomine HCl; Content uniformity test; Tablet dosage form; Market sample analysis.