Abstract

DEVELOPMENT AND VALIDATION OF ESTIMATION OF DIACEREIN AND ACECLOFENAC BY U.V. SPECTROPHOTOMETRIC SIMULTANEOUS METHOD IN DOSAGE FORMS

Nasira Abbasi* and Dr. Vivek Jain

ABSTRACT

A novel, safe, accurate and sensitive spectrophotometric method was developed using 2 M sodium acetate and 2 M sodium benzoate in the ratio of (1:1 v/v) solution as hydrotropic solubilizing agents for the quantitative determination of poorly water-soluble drugs Diacerein and Aceclofenac in tablet dosage form. There was more than 12 fold enhancement in the solubility of Diacerein and Aceclofenac in 2 M sodium acetate and 2 M sodium benzoate (1:1) solution as compared to solubility in distilled water. Diacerein and Aceclofenac show maximum absorbance at 242 and 278 nm respectively. Sodium acetate and sodium benzoate did not show any absorbance above 220 nm and thus no interference in the estimation of drug was seen. The sample follows the Beer’s law in the concentration range of 10 to 50 μg/Ml (r2= 0.999) with mean recovery ranging from 99.750 to 99.778% and 100.083 to 99.611 Diacerein and Aceclofenac respectively. This performed method is simple, economic, safe, rapid, accurate and reproducible. The method is developed and validated according to ICH guidelines and the prescribed values are found to be in a good accordance.

Keywords: UV Spectrophotometer, Diacerein, Aceclofenac, method development, Validation.