Development and Validation of an HPLC Method for the Analysis of Saxagliptin in Bulk Powder
The aim of this study was to develop a simple, rapid and sensitive reverse phase high performance liquid chromatography RP HPLC method for quantification of Saxagliptin in pharmaceutical bulk powder. The chromatographic system employs isocratic elution using a Cosmosil C18 250mm x 4.6ID, Particle size 5 micron . Mobile phase consisting of Methanol and water 70 30 set at flow rate 0.8 ml min. The analyte was detected and quantified at 212nm using ultraviolet detector. The method was validated as per ICH guidelines. The standard curve was found to have a linear relationship r2 0.99 over the analytical range of 10 50 µg ml. For all quality control QC standards in intraday and interday assay, demonstrating the precision and accuracy over the analytical range. Samples were stable during preparation and analysis procedure. Therefore the rapid and sensitive developed method can be used for the routine analysis of Saxagliptin such as dissolution and stability assays of pre and post marketed dosage forms.
Saxagliptin, dipeptidyl peptidase 4 inhibitors, Diabetes mellitus
Dr. Pradnya Lokhande