Development and validation of Carvedilol In RP- HPLC

Abstract

The present study describes the development of a new rapid, simple, sensitive and reproducible RP-HPLC, method for the analysis of Carvedilol that offer certain advantages in its simplicity and sensitivity and applicable in routine analysis. It also describes the development of validation work as per ICH guidelines recommended by the Food and Drug Administration (FDA) of the United States. In order to develop a RP-HPLC,  effective most of the effect should be spent in method development and optimization as this will improve the final method performance. A well developed method should be easy to validate. A method should be developed with the goal to analyse rapidly, the preclinical samples, formulations and commercial samples. Review of literature on drug strongly indicates that there is few method available for determination and validation of carvedilol in bulk and pharmaceutical dosage forms . Keeping in this mind we developed methods for determination and validation of carvedilol in bulk and pharmaceutical dosage forms by RP- HPLC, method with some improvements than the existing methods. The analytical procedure described for assay was specific, linear, precise, accurate, and system suitable for determination of carvedilol in bulk and pharmaceutical dosage forms. The observations of the validation parameters such as accuracy, precision, specificity, linearity, shows that the developed methods can be employed for routine analysis of bulk and tablets form of carvedilol. The result obtained from the validation parameters met the ICH and USP requirement as well as obeys BEER’S law.