NEW ANALYTICAL METHODS & VALIDATION OF EPALRESTAT-BULK & DOSAGE FORMS

Epalrestat is an anti-diabetic drug. It is not official in any pharmacopoeia. Literature survey reveals that only two RP-HPLC methods were developed for Epalrestat but no methods were reported in UPLC and Derivative Spectroscopy for determination of Epalrestat. In the present investigation, we have developed a UV spectrophotometric and UPLC methods for the quantitative estimation of Epalrestat in bulk drug and tablet formulations. The UPLC method is promising with more sensitive accurate and precise compared to the UV spectrophotometric methods. The results obtained with proposed methods confirm the suitability of these methods for tablet dosage forms. The other active ingredients and excipients usually present in the tablet dosage forms did not interfere in the estimation, where some commercial dosage forms were analyses by these methods. The accuracy of the methods was confirmed by the recovery studies. The methods can be used for the routine determination of Epalrestat in bulk and in tablet dosage forms.