Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF BALSALAZIDE FROM CAPSULE FORMULATION

Naveen Kumar G.S.*, Dinesh M., Gokul Nanda G. and Hanumanthachar Joshi

Abstract

Balsalazide is an anti-inflammatory drug used in the treatment of inflammatory bowel disease. It is usually administered as the disodium salt. New, simple and sensitive spectrophotometric methods for the determination of balsalazide have been developed for the quantitative estimation of from balsalazide capsule dosage form. The method was developed and based on the solubility of balsalazide in 0.1 N NaOH. The drug showed maximum absorbance at 454 nm and linearity (Lambert Beer’s Range) was found in concentration range of 10-100 μg/ml and the standard curve equation was found to be y = 0.015x – 0.015 and R2 value 0.998. The results of analysis were validated statistically and by recovery studies. The result of analysis was validated as per ICH guidelines and this method can be used for the routine analysis of balsalazide formulation.

Keywords: Balsalazide, 0.1 N NaOH, UV method, Validation.