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

International Journal of Development Research

Volume: 
14
Article ID: 
27788
4 pages
Research Article

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

Madhuri Lode, Rama Rao Tadikonda, Kiran Rapolu and Dr. Narender Boggula

Abstract: 

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.

DOI: 
https://doi.org/10.37118/ijdr.27788.01.2024
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