European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CHLORDIAZEPOXIDE AND CLIDINIUM BROMIDE IN COMBINED DOSAGE FORMS

Thandra Sridhar*, Edem Balaraju and Linga Sajendra Reddy

ABSTRACT

A new, simple, precise, accurate and reproducible RP-HPLC method for the simultaneous estimation of Chlordiazepoxide and Clidinium bromide in combined dosage forms. Separation of Chlordiazepoxide and Clidinium bromide was successfully achieved on a ACE C8 (150X4.6mm, 5μm Make: Agilent) in an isocratic mode utilizing H3PO4 buffer (pH 3.5): Methanol (50:50%v/v) at a flow rate of 1.0mL/min and with a retention time of 1.905 and 2.857 minutes for Clidinium bromide and Chlordiazepoxide. The method was validated and the response was found to be linear in the drug concentration range of 50μg/mL to 150μg/mL for Clidinium bromide and Chlordiazepoxide. This method was found to be good percentage recovery for Clidinium bromide and Chlordiazepoxide were found to be 100.52% and 100.44% respectively indicates that the proposed method is accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively according validated to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.

Keywords: Clidinium bromide and Chlordiazepoxide.