Estimation of Saxagliptin hydrochloride and Dapagliflozin propendiol monohydrate in combined dosage form
Abstract
Aim of present study is to develop simple, precise, and accurate method for simultaneous quantitative estimation of saxagliptin hydrochloride and dapagliflozin propendiol monohydrate in pharmaceutical tablet dosage form. The method was based on determination of saxagliptin hydrochloride at an absorbance difference between 214.40 nm - 220.0 nm and sapagliflozin propendiol monohydrate at an absorbance difference between 208.0 nm - 209.0 nm. The linearity was obtained in the concentration range of 4-16 μg/ml and 10-22 μg/ml for saxagliptin hydrochloride and dapagliflozin propendiol monohydrate respectively. The suitability of this method was proved by validation in accordance with ICH Q2 (R1) guidelines. The method was found to be accurate with percent recovery 99.30-99.86 % and 100–100.31% for saxagliptin hydrochloride and dapagliflozin propendiol monohydrate respectively. The proposed method was found to be simple and sensitive for routine quality control application of saxagliptin hydrochloride and dapagliflozin propendiol monohydrate used in pharmaceutical tablet dosage
form.
Keywords:
Dapagliflozin propendiol monohydrate, saxagliptin hydrochloride, UV- spectroscopy, dual wavelength
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References
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20. Jani BR, Shah KV, Kapupara PP. Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. Journal of Bioequivalence Studies. 2015; 1(1):1-8.
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22. Naved Ahmed, Obaid Shaikh, Aateka Barrawaz, Sarfaraz Khan, Zahid Zaheer. Development and validation of rapid HPLC method for determination of Aripiprazole in bulk drug and pharmaceutical formulation. Journal of Innovations in Pharmaceutical and Biological Sciences 2017; 4(3): 15-19.
23. Sushil D. Patil, Sunil V. Amurutkar, Chatpalliwar V. A., Chandrashekhar D. Upasani. Development and validation of RP-HPLC method for Empagliflozin and Metformin HCL. Journal of Innovations in Pharmaceutical and Biological Sciences 2017; 4(4): 185-189.
24. Haritha Gali, Vishwanadham Yerragunta. Development and validation of RP-HPLC method for simultaneous estimation of Naproxen and Esomeprazole in pharmaceutical dosage form. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(3): 39-42.
25. Desabattina Sai Jahnavi, Desabattina Venkata Narayana Rao, Yeluri Ramachandra Reddy. RP-HPLC method for the quantification of Metformin and Rosiglitazone in bulk and combined tablet dosage form: method development and validation. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(4): 55-60.
26. Zahid Zaheer, Furquan Nazimuddin Khan, Darakhshan Afreen Shaikh, Sarfaraz Khan, Mirza Shahed Baig, Moizul Hasan. Zero order derivative spectroscopic estimation of olopatadine hydrochloride from eye drops. Journal of Innovations in Pharmaceutical and Biological Sciences 2016, 3(2): 103-107.
2. Frederich R, Alexander JH, Fiedorek FT, Donovan M, Berglind N, Harris S et al. A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for type 2 diabetes. Postgrad Med. 2010; 122(3):16-27.
3. Wei M, Bruce AE, Alexandra AN, Peggy JM, Manorama P, Ravindar NG. et al. A Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor for the Treatment of Type 2 Diabetes J Med Chem. 2008; 51(5):1145–49.
4. Chao EC, Henry RR. SGLT2 inhibition—a novel strategy for diabetes treatment. Nat Rev Drug Dis. 2010; 9(7):551–59.
5. Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B. et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care 2015; 38(3):376-83.
6. Chhabda P, Balaji M, Srinivasarao V, Ramakrishna K, Apparao KM. Devolpment And Validation Of Simple Stability Indicating Rp-Hplc Method For Analysis of Saxagliptin And Its Forced Degradation Impurities In Bulk Drug And Pharmaceutical Dosage Form. Int J Res Dev Pharm Life Sci. 2014; 3(3):993-1003.
7. Shubhangi CD, Madhumita AR, Sanjay GW, Mahendra CB. Quality By Design Approach For The Development And Validation Of Saxagliptin By RP-HPLC With Application To Formulated Forms. Int J Pharm Sci Res. 2016; 7(4): 1670-77.
8. Saiful Md, Taleb H, Sukalyan K, Abdul Md, Rafiquzzaman Md. Development and validation of RP-HPLC method for determination of saxagliptin hydrochloride in bulk and tablet dosage form. World J Pharm Pharm Sci. 2016; 5(5): 107-19.
9. Prasad PBN, Satyanaryana K, Krishnamohan G. Development and Validation of a Method for Simultaneous Determination of Metformin and Saxagliptin in a Formulation by RPHPLC. Am J Analyt Chem. 2015; 6(11): 841-50.
10. Kalaichelvi R, Jayachandran E. Validated spectroscopic method for estimation of saxagliptin in pure and from tablet formulation. Int J Pharm Pharm Sci. 2011; 3(3):179¬-80.
11. Sawant RL, Mhaske SM. Analytical method development for simultaneous estimation of saxagliptin and methyldopa. Asian J. Pharm. Res. 2014; 4(3):134-40.
12. Sanagapati M, Dhanalakshmi K, Nagarjunareddy G, Sreenivasa S. Development and validation of a RP-HPLC method for the estimation of dapagliflozin in API. Int J Pharm Sci Res. 2014; 5(12):5394-97.
13. Shyamala, Nidhi B, Kavitha M, Pooja, Sharma JVC. Validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and dapagliflozin in tablet dosage form. American J of Bio and Pharma Res. 2015; 2(2):109-13.
14. Karuna P, Chitra M, China E, Basaveswara MV. Unique UV spectrophotometric method for reckoning of dapagliflozin in bulk and pharmaceutical dosage forms. Journal of Chem and Pharma Res. 2015; 7(9):45-49.
15. Gajanan VM, Krishna RG, Atul TH. Estimation of Dapagliflozin from its Tablet Formulation by UV-Spectrophotometry. Pharm Methods 2017; 8(2): 102-107.
16. Gandla S, Shruthi S, Rajkumar M, Sudheer D. A new stabilty indicating RP-HPLC method for simultaneous determination of saxagliptine and dapagliflozin in bulk and combined tablet dosage forms. Asian J of Pharma Ana and Med Chem. 2017; 5(3):113-21.
17. Sarath N, Seshagiri Rao J V L N. A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in Combined Tablet Dosage Forms. Inventi Rapid: Pharm Analysis & Quality Assurance 2017; (4):1-11.
18. Advaita B, Deepa R, Zarna S. Development and validation of stability indicating method for the simultaneous estimation of saxagliptin hydrochloride and dapagliflozin using RP-HPLC method in tablet dosage form. World J Pharm Pharm Sci. 2017; 6(10):444-58.
19. Patel PD, Pandya SS. Validated RP - HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin Hydrochloride in Tablet Dosage Form. Int. J. Pharm. Res. Scholars. 2018; 7(1): 9-15.
20. Jani BR, Shah KV, Kapupara PP. Development and Validation of UV Spectroscopic First Derivative Method for Simultaneous Estimation of Dapagliflozin and Metformin Hydrochloride in Synthetic Mixture. Journal of Bioequivalence Studies. 2015; 1(1):1-8.
21. International Conference on Harmonisation. Guideline. ICH. Validation of analytical procedures: text and methodology. Q2 (R1). Geneva: ICH; 2005. 17.
22. Naved Ahmed, Obaid Shaikh, Aateka Barrawaz, Sarfaraz Khan, Zahid Zaheer. Development and validation of rapid HPLC method for determination of Aripiprazole in bulk drug and pharmaceutical formulation. Journal of Innovations in Pharmaceutical and Biological Sciences 2017; 4(3): 15-19.
23. Sushil D. Patil, Sunil V. Amurutkar, Chatpalliwar V. A., Chandrashekhar D. Upasani. Development and validation of RP-HPLC method for Empagliflozin and Metformin HCL. Journal of Innovations in Pharmaceutical and Biological Sciences 2017; 4(4): 185-189.
24. Haritha Gali, Vishwanadham Yerragunta. Development and validation of RP-HPLC method for simultaneous estimation of Naproxen and Esomeprazole in pharmaceutical dosage form. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(3): 39-42.
25. Desabattina Sai Jahnavi, Desabattina Venkata Narayana Rao, Yeluri Ramachandra Reddy. RP-HPLC method for the quantification of Metformin and Rosiglitazone in bulk and combined tablet dosage form: method development and validation. Journal of Innovations in Pharmaceutical and Biological Sciences 2016; 3(4): 55-60.
26. Zahid Zaheer, Furquan Nazimuddin Khan, Darakhshan Afreen Shaikh, Sarfaraz Khan, Mirza Shahed Baig, Moizul Hasan. Zero order derivative spectroscopic estimation of olopatadine hydrochloride from eye drops. Journal of Innovations in Pharmaceutical and Biological Sciences 2016, 3(2): 103-107.
Published
30/06/2018
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Suthar, A. M., Prajapati, L. M., Joshi, A. K., Patel, J. R., & Kharodiya , M. L. (2018). Estimation of Saxagliptin hydrochloride and Dapagliflozin propendiol monohydrate in combined dosage form. Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 3(2), 01-07. Retrieved from https://saap.org.in/journals/index.php/jiaps/article/view/194
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