Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CHLORTHALIDONE IN BULK AND IN FORMULATION

Greeshma S.*, Anusreya M., Aswathy M., Harsha P., Muhammed Farhan and Sucheeta

ABSTRACT

The study aims to develop a simple, sensitive, rapid, accurate and precise difference spectrophotometric method for the determination of Chlorthalidone in bulk drug and tablet dosage form. In to two sets of 10 ml volumetric flasks, aliquots of standard drug solution (100μg/ml) in methanol were transferred and diluted the first set with 0.1NHNO3 and the other with 0.1N NaOH to get a concentration of 2-12 μg/ml for both the sets. Chlorthalidone has exhibited maximum absorbance at about 263nm when acidic solution was kept in the reference cell and basic solution in sample cell respectively. Beer’s law was obeyed in the concentration range of 2-12μg/ml with a linear regression value 0.991. Interday and Intraday studies showed high degree of repeatability. Recoveries obtained do not differ significantly from 100% showed that there was no interference from the common excipients used in the tablet formulation indicating accuracy and reliability of the method. So, the developed difference spectrophotometric method can be used for the routine analysis of bulk and formulation.

Keywords: Chlorthalidone, Difference Spectrophotometry, Nitric acid, Sodium Hydroxide, Validation Parameters.