ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND SAXAGLIPTINAbstract
The present study aims to develop a verse phase HPLC method for the simultaneous estimation of Metformin and Saxagliptin. In bulk and pharmaceutical dosage form and to validate the proposed method in accordance with ICH guidelines for the intended analytical application. Multiple trials were run to Metformin and Saxagliptin, get eluted with good peak symmetric properties. Mobile phase Phosphate buffer: Methanol: Acetonitrile (40:5:55), Column Hypersil silica and flow rate 1.0ml, detection wavelength at 233nm, column temperature 300C and diluents Water: Methanol (50:50). Column Hypersil silica and flow rate 1.0 ml, detection wavelength at 210 nm conditions were finalized as an optimized method. This method was validated for Stability Data, System suitability, Precision, Linearity, Accuracy, Robustness, Ruggedness, LOD, and LOQ. System suitability parameters were studied by injecting the standard five times, and results were well under the acceptance criteria. Linearity study was carried out between 25% to 150% levels, r2 value found 0.999. By using the above method, assay of the marketed formulation was carried out 99.63% was present. So, this method can be used to estimate Metformin and Saxagliptin in Pharmaceutical dosage form for routine analysis purposes.