Abstract

DEVELOPMENT AND VALIDATION OF A NOVEL UV-DERIVATIVE SPECTROSCOPIC METHOD FOR ESTIMATION OF GLICLAZIDE TABLETS

Dr. Usharani N*, Keerthana K, Sarika M, Revathi D, Kusuma D, Kumari VY

Abstract

In the present study, derivative spectrophotometric methods have been developed and validated for the determination of Gliclazide in bulk and in tablet dosage forms. The second, third and fourth order derivative spectroscopy was applied for the estimation of Gliclazide using zerocrossing method. These methods were adopted to eliminate the spectral interference. Based on spectrophotometric characteristics of Gliclazide a signal of second (219nm), third (204nm) and fourth (213nm) order derivative spectra were found to be relevant for quantification. The literature survey showed that no analytical method was reported so far for the estimation of Gliclazide in tablet dosage form using derivative spectroscopy, though few simple UV-spectroscopic and HPLC methods exist. Hence the authors made an attempt to develop simple, accurate, sensitive, reliable and rapid derivative spectroscopic methods for the quantification of Gliclazide. The proposed methods obeyed Beer’s law in the concentration range of 2-10μg/ml and were validated as per the ICH guidelines.

Keywords: Gliclazide, Derivative spectroscopy, Validation.