Development and Validation of a Rapid Stability-Indicating HPLC Method for Determination of Carbamazepine in Pure and Dosage Forms

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 C 18 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 (H 2 O 2), 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 (R 2 =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.

A Stability Indicating Method was Developed and Validation for the Estimation of Carbamazepine in Bulk and Tablet Dosage form by UV-Spectroscopic Techniques

“…According to studies on stress degradation, UV-spectroscopic analysis of carbamazepine solutions demonstrated no indications of insignificance degradation 14 .…”

“…[86] CODEN (USA): JDDTAO HPLC method 14 , determination of assay of carbamazepine CR tablets by HPLC method 15 . According to the previously reported analytical methods, our main aim is to develop robust, rapid, sensitive, selective, linear, and precise different types of UV-spectrophotometric methods to determine and validate the method as per the United States Pharmacopeia 16 and ICH guidelines 17 .…”