Volume : 2, Issue : 11, November - 2013

Analytical Method Validation of Stability–Indicating HPLC Method for Determination of Assay of Carbamazepine CR Tablets

Ajay Kumar Gupta, P. K. Patel

Abstract :

This paper deals with the development and validation of stability indicating high performance liquid chromatographic method for the quantitative determination of Carbamazepine CR Tablets form. Study of an analytical method for the determination of Carbamazepine drug and also validate the method as per the ICH guideline and required acceptance criteria. The method was developed by using Hypersil ODS V column (250×4.6 mm, 5 µm particle sizes) containing mobile phase Water: Methanol: Methylene chloride in ratio (30: 30: 3) total volume 630 ml. The flow rate was set at 1.5 mL/minute and the injection volume was 20μL. The run time of injection is near about 25 min. In this method use Shimadzu HPLC with UV Detector at 230 nm . The linearity of method was 100.50 to 301.50 µg/ml, the correlation coefficient was found to be 0.9998. The liquid chromatographic method was validated with respect to specificity, precision (% RSD about 0.28%), Stability an analytical solution (% deviation from initial area count found in limit ±2%), accuracy, ruggedness and robustness are uses parameter.