A simple and sensitive ultraviolet spectrophotometric method for quantitative estimation of a model API gliclazide in presence of excipients is described to avoid false estimation due to presence of soluble or insoluble impurity. UV detection was performed at 226 nm, 221 nm and 231 nm and the calibration curve was prepared between the resultant of absorbance at these three wavelengths according to the equation [226 nm - (221 nm + 231 nm)/2] and the concentration of gliclazide. The calibration curve was found to be linear over concentration range tested (04-28 μg/ml) having limit of detection of 0.45 μg/ml and limit of quantification 1.36 μg/ml. Percent relative standard deviations, representing precision, for pure as well as impure solutions were found to be within acceptable limits i.e. always less than 1.99 and 2.00 respectively for pure and impure solution. Mean percent recovery of 99.21%-102.04% and 102.06%-103.74% for pure and impure solution respectively indicates that the developed method is accurate. Conclusively, the developed method can be effectively applied for the estimation of gliclazide in pure as well as impure solutions and it was seen that the analyte in both types of solutions can be detected from same calibration curve accurately and precisely.
Key words: Pure, Impure, Excipients, UV spectrophotometric method, Gliclazide.