RP–HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN BULK AND TABLET DOSAGE FORMS

M. Laxmi; R.V. Valli Kumari; S. Marakatham; M. Sathish Kumar

Volume : IX, Issue : X, October - 2019

RP–HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN BULK AND TABLET DOSAGE FORMS

M. Laxmi, R. V. Valli Kumari, S. Marakatham, M. Sathish Kumar

Abstract :

This investigation furnishes an analytical method on reverse phase high performance liquid chromatography with PDA detection method for the simultaneous determination ertugliflozin and sitagliptin in bulk and in its tablets. The separation and assay of ertugliflozin and sitagliptin was done using Cosmicsil C8 column (250 mm × 4.6 mm I.D., 5 μm size particle) in isocratic mode of elution . The optimized mobile phase was 0.1 Molar dipotassium hydrogen phosphate and methanol (65:35, v/v). The eluted analytes are monitored at 225 nm wavelength. The method separated ertugliflozin and sitagliptin within a 7 min run time. The parameters proposed by International Conference of Harmonization guidelines were concluded by validation i.e., system suitability , linearity , limit of detection , limit of quantification , selectivity , accuracy precision and robustness . Linearity of ertugliflozin and sitagliptin was in concentration range of 7.5 –22.50 µg/ml and 50–150 µg/ml , respectively by the method . The LOD was 0.087 and 0.071 μg/ml for sitagliptin and ertugliflozin , respectively . The LOQ was 0.291 μg/ml and 0.237 μg/ml for sitagliptin and ertugliflozin, respectively . The developed method was assessed through analysis of sitagliptin and ertugliflozin in the available tablet dosage form . The percent recoveries (± RSD) were 99.60 ± 0.027 and 99.83 ± 0.017 for sitagliptin and ertugliflozin , respectively. The results proved the non interference from the tablet excipients with good recovery and precision . Hence the method can be suggested for the routine quality control analysis of sitagliptin and ertugliflozin.