Abstract

VALIDATED DIFFERENCE ABSORBANCE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TINIDAZOLE IN BULK AND DOSAGE FORMS.

Malathi Raghunath*, Amol Dhamne, Swapnali Borude and Anoop Singh

Abstract

The aim of the present study was to develop a simple, accurate,precise, reproducible and economical difference UVspectrophotometric method for quantitative estimation of Tinidazole(TNZ) in bulk and its formulation. The solvent used for analysis was0.1N HCl and 0.1N NaOH to induce spectral changes in TNZ so as toeliminate unwanted absorption arising from pH insensitive substancesin formulations of TNZ. The absorbance was recorded at λmax (276nm) of TNZ in 0.1N HCl and λmax (366nm) of TNZ in 0.1N NaOH.The method was validated for parameters such as linearity, accuracy,precision and limit of quantification, limit of detection, ruggedness androbustness as per ICH guidelines. The proposed method is thusrecommended for routine analysis of TNZ in bulk and tabletformulations without any interference of excipients. The use of 0.1NHCl and 0.1N NaOH was found to be quite satisfactory for the estimation of TNZ andtherefore does not require higher concentrations of HCl and NaOH for sample preparation asreported earlier.

Keywords: Tinidazole, Validation, ICH guidelines, Difference absorbance spectrophotometric method.