Develoment and Validation by UV Spectrophotometric method for the Determination of Sitagliptin in Bulk and its Formulation

Back ground: Validation is a documented program that provides a high degree of assurance that a facility or operation will consistently produce product meeting a predetermined specification.Sitagliptin is the oral hypoglycemic drug. Objective: The main objective is to develop and validate the UV-spectrophotometric method for the estimation of sitagliptin in bulk and pharmaceutical formulations as per ICH guidelines. Method: The estimation was carried out using HPLC grade methanol as solvent and quantitation was achieved using double beam UV spectrophotometer at 265 nm. Results: The λmax of sitagliptin in methanol was found to be 265 nm. The drug follows linearity in the concentration range 1-5 µg/ml with correlation coefficient value 0.9998. The results of analysis were validated by recovery studies. The recovery was found to be 99.87 to 100.18%. The relative standard deviation was found to be <2.0 % in all cases. Conclusion: The above method was a rapid and cost-effective quality control tool for routine analysis of sitagliptin in bulk and in pharmaceutical dosage form. The method can be useful for the day-to-day routine analysis in the quality control departments of bulk and pharmaceutical formulations industries.