Abstract

A new, simple, rapid and accurate stability-indicating HPLC method was developed and validated for quantitative determination of carbamazepine (CBMZ) in pure and dosage forms. An isocratic HPLC method, using a C₁₈ reversed phase column (150 mm x4.6 mm i.d., particle size 5 μm) with isocratic binary mobile phase consisting of methanol and water (70:30,V/V), was investigated to separate the drug from its stress degradation products. The flow rate was 1.5 mL min^-1 at ambient temperature and photo diode array (PDA) detector was used at 285 nm for detection. The elution time of CBMZ was found to be 2.324±0.003 minutes. The developed method was validated for system suitability, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability and robustness. Stability tests were done through exposure of the analyte solution for five different stress conditions: Reflux with 1.0 mol L^-1 hydrochloric acid (HCl), reflux with 1.0 mol L^-1 sodium hydroxide (NaOH), reflux with 30% hydrogen peroxide (H₂O₂), exposure to ultra violet radiation (UV) radiation and heating. The calibration curve was found to be linear with the equationy=0.19677x-0.306, with a correlation coefficient of (R²=0.9999) over a concentration range of 2.0-24 µgmL^-1. The limits of detection and quantification were 0.02 and 0.062 µgmL^-1, respectively. The recovery value of this method is 99.80% and the reproducibility is with in 1.23.

Keywords

Carbamazepine, Rapid stability indicating LC-method, C₁₈ column, Method validation, Stress degradation, Dosage forms