Validation and Application of a High-Performance LiquidChromatography Method for Estimation of Sitagliptin Phosphate fromBulk Drug and Pharmaceutical Formulation

摘要

A gradient LC method was developed for determination and quantitation of Sitagliptin in bulk drug and pharmaceutical formulations. The separation was accomplished on a symmetry reversed phase C18 column, 75 mm x 4.6mm I.D., 3.5μm column using mobile phase consist of acetonitrile and 0.03% formic acid at flow rate of 0.3ml/min. The eluents were monitored with a UV detector set at 268 nm as detection wavelength. The investigated validation elements showed the method has acceptable specificity, accuracy, linearity, precision, robustness. This method was found to be linear within range of 100 to 500 μg.ml~(-1) (r=0.9999). The method could be of use for rapid and routine quality control analysis of Sitagliptin. Thus, the developed method can be used for process development as well as quality assurance of Sitagliptin in bulk drug and pharmaceutical formulations.