ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SIMVASTATIN AND SITAGLIPTIN

Abstract

A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Simvastatin and Sitagliptin pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Inertsil ODS-3 C 18 (75 mm*4.6 mm) 5 microns Short column, Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 0.05 M Ammonium acetate: CAN 60:40. The flow rate was set to 1.0 mL.min^-1 with the responses measured at 253 nm using Shimadzu SPD-20A Prominence UV- Visible detector. Retention time of simvastatin and sitagliptin were found to be 3.260 and 2.136 minutes. Linearity was established for simvastatin and sitangliptin in the range of 25 to 150 and 10 to 60 µg.mL^-1 with correlation coefficient 1. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of in simvastatin and sitangliptin pharmaceutical tablet dosage form.