Method Development and Validation of Metformin in Pure and Its Tablet Dosage Form by using RP-HPLC

Dr. Hareesh Dara, Meesa Rajendar, Dr. D Siva Dinesh
St John College of Pharmcy, Hasanparthy, Hanamkonda, Telangana, India

A B S T R A C T
High Performance Liquid Chromatography is now one of the most powerful tools in analytical chemistry. It has the ability to separate, identify, and quantitative the compounds that are present in any sample that can be dissolved in a liquid. In the present investigation, a simple, sensitive, precise and accurate RP-HPLC method was developed for the quantitative estimation of Metformin in bulk drug and pharmaceutical dosage forms. The selected method was used for method development of the drug molecules Metformin as per ICH guidelines. By taking different mobile phases and by changing columns trials have been done and validation process is done for the optimized method. Metformin was freely soluble in ethanol, methanol and sparingly soluble in water. Methanol: TEA Buffer was chosen as the mobile phase. The solvent system used in this method was economical. The %RSD values were within 2 and the method was found to be precise.The results expressed in Tablesfor RP-HPLC method was promising. The RP-HPLC method is more sensitive, accurate and precise compared to the Spectrophotometric methods. This method can be used for the routine determination of Metformin in bulk drug and in Pharmaceutical dosage forms.
Keywords: Metformin, RP-HPLC, Method Development.