Deepthi R, Gowri Sankar D
Deepthi R1*, Gowri Sankar D2
1Research Scholar, Department of Pharmaceutical Analysis and QA, Andhra University, Visakhapatnam - 530003, Andhra Pradesh, India.
2Professor, Department of Pharmaceutical Analysis and QA, Andhra University, Visakhapatnam - 530003, Andhra Pradesh, India.
Volume - 14,
Issue - 9,
Year - 2021
Aim: The proposed study aimed to develop a novel ultra-performance liquid chromatography (UPLC) method for the estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet dosage form and validate the method in accordance with the International Conference on Harmonization guidelines. Methods: The optimized conditions for the developed UPLC method are Acquity UPLC HIBRA C18 (100mm × 2.1mm, 1.8µ) column maintained at 30°C with a mobile phase consisting of Buffer (0.01N sodium hydrogen phosphate) pH adjusted to 4.0 with dil. orthophosphoric acid: Acetonitrile in the ratio of 60:40%v/v on isocratic mode at a flow rate of 0.3mL/min. Results and conclusion: The sample was detected at 220nm. The retention time for Ertugliflozin and Sitagliptin was deemed at 1.873min and 1.260min. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness, and solution stability. The method obeyed Beer’s law in the concentration range of 3.75µg/mL to 22.5µg/mL for Ertugliflozin and 25µg/mL to 150µg/mL for Sitagliptin with a correlation coefficient of 0.999 for Ertugliflozin and Sitagliptin respectively. Forced degradation studies were conducted by exposing the drug solution to numerous stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was considered within the limits, indicating that the drug is stable in stressed conditions. The developed method for the estimation of Ertugliflozin and Sitagliptin can be utilized for the routine analysis of Pharmaceutical dosage form.
Cite this article:
Deepthi R, Gowri Sankar D. A Novel UPLC Method for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2021; 14(9):4859-2. doi: 10.52711/0974-360X.2021.00844
Deepthi R, Gowri Sankar D. A Novel UPLC Method for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2021; 14(9):4859-2. doi: 10.52711/0974-360X.2021.00844 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-9-58
1. Cinti F, Moffa S, Impronta F, Cefalo CM, et al. Spotlight on Ertugliflozin and its Potential in the Treatment of type 2 diabetes: evidence to date, Drug Design Development and Therapy, 2017; 11: 2905-2919.
2. Ghazala K, Dinesh S, Agrawal YP, Neetu S, et al. Simultaneous estimation of metformin and sitagliptin in tablet dosage form. Asian Journal of Biochemical and Pharmaceutical Research, 2011; 2: 223-9.
3. Ramalingam P. et al. “Stability-Indicating RPHPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets.” Indian Journal of Pharmaceutical Sciences, 2014; 76(5): 407–414.
4. Meher Vijay Dalawai et al, Development and Validation of Stability Indicating Assay Method by HPLC for the Analysis of Sitagliptin phospahte in bulk drug substances. Journal of Chemical and Pharmaceutical Research, 2015; 7(10): 781-787.
5. Vasanth P M et al, Method development and validation of sitagliptin and metformin using reverse phase HPLC method in bulk and tablet dosage form, Der Pharmacia Lettre, 2013, 5 (5): 168-174.
6. Hanan A.et al, Chromatographic methods for the simultaneous determination of binary mixture of Saxagliptin HCl and Metformin HCl, Bulletin of Faculty of Pharmacy, Cairo University, 2017; 55(2): 311-317.
7. S.N. Konari, Stability indicating validated RP-HPLC technique for the analysis of multicomponent anti-diabetic drug combos in pharmaceutical dosage forms, Karbala International Journal of Modern Science, 2015; 1: 39-48.
8. R. Lavanya MD. Yunoos. Development and Validation of RP-HPLC method for the estimation of Sitagliptin Phosphate in Bulk and its Tablet Dosage Form; Journal of Advanced Pharmacy Education and Research, 2013; 3(4): 475-479.
9. Ghazala K. Dinesh S, Agarwal YP, Neetu S, Avinash J. Gupta AK. Simultaneous estimation of metformin and Sitagliptin in tablet dosage form, Asian Journal of Biochemical and Pharmaceutical Research, 2011; 2: 223-9.
10. Herman GA. Stevens C, Van Dyck K, Bergman A et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl IV, in healthy subjects: Results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Prarmacol Ther. 2005; 78(6): 675-88.
11. Plosker GL, Sitagliptin: A review of its use in patients with type 2 diabetes mellitus, Drugs. 2014; 74(2): 22342.
12. D. China babu, C. Madhusudhana Chetty and S.K. Mastanamma. Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation, Oriental journal of Chemistry, 2018, 34(5).
13. P. Venkateswara Rao. A LakshmanaRao, S.V.U.M Prasad. A new stability indicating RP-HPLC method for simultaneous estimation of Ertugliflozin and sitagliptin in bulk and pharmaceutical dosage form its validation as per guidelines. Indo American Journal of Pharmaceutical Sciences, 2018, 5(4): 2616-2627.
14. P Harshalatha, K B Chandrasekhar, MV Chandrasekhar. A novel RP-HPLC method for simultaneous determination of Ertugliflozin and Sitagliptin in bulk and tablet dosage form, International Journal of Research in Pharmaceutical Sciences, 2018, 9(3): 1042-1050.
15. Validation of Analytical procedures, ICH Harmonised Triplicate Guidelines, Q2 B 1997.
16. ICH: Q2 (R1). Validation of Analytical Procedures: Text and Methodology, Geneva: ICH: Q2 (R1); 2005.
17. Ngwa G. Forced degradation studies as an integral part of HPLC stability-indicating method development. Drug Delivery Technol 2010; 10:56-9.
18. Deepthi R, Gowri Sankar D. Stability-Indicating Method Development and Validation for the Simultaneous Estimation of Glecaprevir and Pibrentasvir in Pharmaceutical Dosage Form by UPLC. Journal of Pharmaceutical Sciences and Research, 2019; 11(8): 2838-2843.