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Development and validation of a RP-HPLC method for the determination of chlordiazepoxide in formulations
Author(s): Korrapati U. Maheswar, Sriranga G. Kalyani and Chintala Rambabu*
A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Chlordiazepoxide in tablet dosage form. Isocratic elution at a flow rate of 1mL/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5μm in particle size) column at ambient temperature. The mobile phase consisted of Methanol: Acetonitrile: 0.1%OPA in 50:40:10 v/v, (pH 4.7). The UV detection wavelength was 217 nm and 20μL sample was injected. The retention time for Chlordiazepoxide was 3.58 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Chlordiazepoxide in tablet dosage form and bulk drug.