Preformulation Study And Method Development And Validation For The Estimation Of Metformin In Marketed Formulation By Spectrophotometric Method

Abstract

In present study preformulation of metformin was performed in which physiochemical properties and other parameters of drug were studied. Physiochemical parameters such determination of solubility, melting point, λ_max scan using UV-spectrophotometry, FT-IR spectrophotometry were performed in this study. The obtained data from these studies were matched with the data given in standard monographs to confirm the authenticity of procured drug. Also a simple, UV spectrophotometric method was developed for determination of metformin in synthetic mixture. Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines.  The UV spectrophotometric determinations were performed at 232 nm using water as a solvent. The linearity range for stavudine was 2-10μg/ml for both HPLC and UV method. The linearity of the calibration curves for each analyte in the desired concentration range was good (r2 >0.999) by UV method. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. UV method which implied that UV spectroscopy can be a cheap, reliable and less time consuming alternative for chromatographic analysis.