Development and Validation of a Smart Analyti...

Development and Validation of a Smart Analytical UV Spectrophotometric Method for Chlorhexidine Gluconate and Metronidazole Estimation in Synthetic Mixtures

Author Name : Yogesh. N. Gholse, Dinesh. R. Chaple, Rahul. H. Kasliwal, Alpana J. Asnani, Manjusha P. Yeole

ABSTRACT

A thorough review of the literature revealed that none of the most widely used pharmacopeias or journals include a technique for simultaneous assessment of Chlorhexidine Gluconate and Metronidazole in synthetic mixtures using UV/Visible spectroscopy. As a result, it was deemed critical to construct a system that would serve as a reliable, precise UV technique for the simultaneous estimation of CHG and MTZ. CHG and MTZ showed λmax at 231 nm and 320 nm respectively, and iso-absorptive point at 279 nm in Phosphate buffer pH 6.8 prepared with water: methanol (70:30) dissolvable solvent system. In the concentration range of 2-20 g/ml, both agents obey Beer Lambert's law, with r² values of 0.9990 and 0.9998 indicating excellent linearity. According to the ICH criteria, the technique has been statistically and quantitatively verified in terms of linearity, precision, LOD, LOQ, accuracy, and specificity.The LOD for CHG and MTZ were determined to be 1.42 and 0.64 g/ml, respectively, whereas the LOQ were 4.30 and 1.93 g/ml. The percent recovery at a recovery level of 80%, 100% & 120% for CHG was found to be 99.54, 99.56 & 99.66 & for MTZ 99.70, 99.56 & 99.44 respectively. Intra-day, Inter-day & precision analysis by different analysts was found to be 0.146, 0.112, 0.195 %RSD for CHG & 0.097, 0.125, 0.161 % RSD for MTZ. Sandell's sensitivity was discovered to be adequate and this shows that very little measure of the two medications can be successfully recognized by this technique. Finally, it was concluded that the developed validated method was helpful and appropriate for the regular quality analysis and simultaneous determination of drug products containing CHG and MTZ in combination.

Keywords: Chlorhexidine Gluconate, Metronidazole, Synthetic mixture, Simultaneous estimation, UV-Visible spectrophotometric method