METHOD DEVELOPMENT AND VALIDATION OF DISSOLUTION METHOD FOR SITAGLIPTIN TABLETS BY UPLC
AbstractA fast, efficient and defined method was developed for the real-time assessment of Sitagliptin in tablet dosage form. Dissolution method was developed and carried out to predict in-vivo drug release profiles of Sitagliptin tablets. Rate and extent of dissolution of Sitagliptin tablets was studied in different dissolution medias i.e. 0.1 N HCL, pH 4.0 Acetate buffer and pH 6.8 Phosphate buffer using USP Type 1 dissolution apparatus with a RPM of 100. Ultra performance liquid chromatography was performed using BEH C18 Column (2.1x 50mm, 1.7µm). Moving phase containing Phosphate Buffer of pH 7.2, Acetonitrile and Methanol in ratio 60:20:20v/v/v was pumped through the column at 1 mL/min flow rate. Run time is 3 minutes. Injection volume is 1.7μL and column is maintained at a temperature of 25°C. Selected wavelength is 210 nm. The Dissolution method was developed and validated and was found to be Precise, Accurate, Linear in a Concentration Range of 25 % to 175 % of Test concentration. Sitagliptin retention time was found to be 1.592 minutes. As the Retention time and Runtime are less, the method is modest and efficient and can be used in industries for routine quality control tests.
Article Information
31
2868-2874
643 KB
141
English
IJPSR
N. Shriya
Department of Pharmaceutical Analysis, Centre for Pharmaceutical Sciences, IST, Jawaharlal Nehru Technological University, Hyderabad, Telangana, India.
shriyareddy.pharma@gmail.com
28 July 2024
30 August 2024
31 August 2024
10.13040/IJPSR.0975-8232.15(9).2868-74
01 September 2024
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