Spectrofluorimetric Determination of Nateglinide in Pharmaceutical Preparations

Abstract

In this study, Selective assay methods have been presented for the analysis of nateglinide in tablets. The assay involves derivatization with 5-(dimethylamino) naphthalene-1-sulfonyl chloride (dansyl chloride) which is a specific reagent in the analysis of primary and secondary amines. Optimum conditions of the reaction between nateglinide and dansyl chloride were investigated and it was found that the reaction proceeds quantitatively at pH 11.0, 40 0C in 10 min when the mole ratio of reagent to the drug was 16. After the completion reaction, the derivative was extracted with dichloromethane from the reaction medium and the fluorescence intensity was measured at 517 nm with excitation at 397nm. The developed method was successfully applied to the assay of nateglinids in tablets and the results were compared statistically with those obtained by pharmacopeia method (USP XXXIV). There is no significant difference between the two methods in the respect of mean values and the standard deviations at 95 % confidence level.

Keywords: Nateglinide, 5-(dimethylamino) naphthalane-1-sulfonyl chloride (Dansyl Chloride), Derivatization, Determination, Spectrofluorimetric method.

DOI: 10.7176/JSTR/5-8-06