Author(s):
M. M. Eswarudu, G. Ouchitya, N. Sudhakar Reddy, M. Deekshitha, P. Srinivasa Babu
Email(s):
eswarmunnangi@gmail.com
DOI:
10.52711/2231-5675.2023.00007
Address:
M. M. Eswarudu*, G. Ouchitya, N. Sudhakar Reddy, M. Deekshitha, P. Srinivasa Babu
Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, 522213, Andhra Pradesh, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 1,
Year - 2023
ABSTRACT:
Pharmaceutical analysis is necessary at all stages of the drug development process, including formulation development, stability studies, and quality control. It is also used for characterizing the composition of different dosage forms in quantitative and qualitative ways. Comprehensive literature survey forms the foundation stone for the focused analysis of research activity. This review article represents the collection and discussion of various analytical methods available in the literature for the determination of oral anti-diabetic drugs like Empagliflozin (EMPA), Linagliptin (LINA) and Metformin hydrochloride (MET) for the treatment of type II diabetes mellitus, consisting of UV, TLC, HPTLC, and HPLC. The anticipated review provides details about the comparative utilization of various analytical techniques for the determination of EMPA, LINA and MET. This review article can be effectively explored to conduct future analytical investigation for the estimation of selected drugs in pharmaceutical and biological samples.
Cite this article:
M. M. Eswarudu, G. Ouchitya, N. Sudhakar Reddy, M. Deekshitha, P. Srinivasa Babu. Review on Analytical Methods for Estimation of Antidiabetic Drugs: Empagliflozin, Linagliptin and Metformin Hydrochloride. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):42-6. doi: 10.52711/2231-5675.2023.00007
Cite(Electronic):
M. M. Eswarudu, G. Ouchitya, N. Sudhakar Reddy, M. Deekshitha, P. Srinivasa Babu. Review on Analytical Methods for Estimation of Antidiabetic Drugs: Empagliflozin, Linagliptin and Metformin Hydrochloride. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):42-6. doi: 10.52711/2231-5675.2023.00007 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-1-7
REFERENCES:
1. Empagliflozin drug profile: https://pubchem.ncbi.nlm.nih.gov/compound/Empagliflozin
2. Linagliptin drug profile: https://pubchem.ncbi.nlm.nih.gov/compound/Linagliptin
3. Metformin Hydrochloride drug profile: https://pubchem.ncbi.nlm.nih.gov/compound/Metformin
4. https://www.rxlist.com/trijardy-xr-drug.html
5. https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-only-triple-combination-tablet-jardiancer-adults
6. Patel et al. Simultaneous quantification of Empagliflozin, linagliptin and metformin hydrochloride in bulk and synthetic mixture by RP–LC method. Future Journal of Pharmaceutical Sciences. 2021;7(182):1-10. Doi: 10.1186/s43094-021-00332-1
7. Kiran T. Naga Ravi et al. Development and validation of RP-HPLC method for the simultaneous estimation of linagliptin, empagliflozin and metformin in solid dosage forms. Asian Journal of Pharmaceutical Analysis. 2020;10(3):117-124. Doi:10.5958/2231-5675.2020.00021.6
8. Sunitha Gurrala et al. Quality by design approach for chromatographic analysis of Metformin hydrochloride, empagliflozin and linagliptin. Journal of chromatographic science. 2022;60(1):68-80. Doi: https://doi.org/10.1093/chromsci/bmab030
9. Naazneen S, Sridevi A. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of empagliflozin and linagliptin in tablet formulation. Der Pharmacia Lettre. 2016:8(17):57-65.
10. Udai Bhan Singh Rathore et al. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Empagliflozin and Linagliptin in Solid Dosage Forms. European Journal of Molecular and Clinical Medicine. 2020;7(1):4666-4673.
11. Lakshmana Rao A et al. RP-HPLC method development and validation for simultaneous quantification of empagliflozin and linagliptin. Indian drugs journal. 2019; 56 (5):68-71. Doi: https://doi.org/10.53879/id.5 Linagliptin 6.05.11150.
12. Mohamed Rizk et al. Development and validation of thin-layer chromatography and high-performance thin-layer chromatography methods for the simultaneous determination of linagliptin and empagliflozin in their co-formulated dosage form. Journal of Planar Chromatography. 2020; 33:647–661.doi:10.1007/s00764-020-00074-5
13. Mohamed Rizk et al. Development and validation of thin-layer chromatography and high-performance thin-layer chromatography methods for the simultaneous determination of linagliptin and empagliflozin in their co-formulated dosage form. Journal of Planar Chromatography. 2020; 33:647–661.Doi: 10.1007/s00764-020-00074-5
14. Rithesh P Bhole et al. Stability indicating HPTLC method for simultaneous estimation of empagliflozin and linagliptin in pharmaceutical formulation. Analytical Chemistry Letters. 2017;7(1):76-85
15. Sachin S. Rane et al. Development and validation of UV spectrophotometric method for simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and pharmaceutical dosage form. Doctrines of Integrative Medicine, Pharmacy and Science International Journal. 2021;01(01):44-53
16. Vinay Kumar D et al. A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Empagliflozin in Tablet Dosage Forms. International Research Journal of Pharmacy and Medical Sciences. 2018;1(5):16-22
17. Alaa S. Amin et al. Simultaneous for the Estimation of Metformin and Empagliflozin in Pharmaceutical Dosage Form by HPLC Method. Journal Of Pharmacy and Biological Sciences. 2019;14(1):75-80. Doi:10.9790/3008-1401037580
18. Manoj Kumar K. Munde et al. A Novel Validated Stability Indicating Analytical Method for Simultaneous Quantification of Metformin Hydrochloride and Empagliflozin in Bulk and Marketed Formulation by HPTLC using Box-Wilson Experimental Design Approach. 2020;54(3):S644-S656.Doi: 10.5530/ijper.54.3s.164
19. Praful et al. Development and validation of HPTLC method for estimation of metformin hydrochloride and empagliflozin in combined tablet dosage form using quality by design approach. Pharma Science Monitor. 2019;10(2):83-100
20. Patil Sushil D. Development and validation of UV Spectrophotometric method for simultaneous estimation of Empagliflozin and Metformin Hydrochloride in bulk drugs. Asian Journal of Pharmaceutical analysis. 2017;7(2):117-123. Doi: http://dx.doi.org/10.5958/2231-5675.2017.00019.9
21. Vijaya Sri K et al. A Rapid RP-HPLC Method development and Validation for the Analysis of Linagliptin in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2015;5(1):16-20.
22. Sushil D. Patil et al. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian Journal of Pharmaceutical Analysis. 2016;6(4):201-206. Doi: https://doi.org/10.5958/2231-5675.2016.00030.2
23. Sushil D. Patil et al. Development and Validation of Simple UV- Spectrophotometric Method for the Determination of Empagliflozin. Asian Journal of Pharmaceutical Analysis. 2017;7(1):18-22. Doi: https://doi.org/10.5958/2231-5675.2017.00004.7
24. Shaik Bima Benazir et al. Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021;11(2):123-126. Doi: http://dx.doi.org/10.52711/2231-5675.2021.00021
25. Rajan V. Rele. UV Spectrophotometric Estimation of Metformin hydrochloride by Area under Curve Methods in Bulk and Pharmaceutical Dosage Form. Asian Journal of Research Chemistry. 2019;12(3):187-190. Doi: https://doi.org/10.5958/0974-4150.2019.00035.X
26. Vaishali P. Shelke. Development and Validation of RP-HPLC Method for the Estimation of Gemigliptin and Metformin Hydrochloride. Asian Journal of Pharmaceutical Analysis. 2021;11(4):259-262. Doi: https://doi.org/10.52711/2231-5675.2021.00044
27. Nachiket S. Dighe et al. Quantitative Estimation and Validation of Dapagliflozin and Metformin Hydrochloride in Pharmaceutical Dosage form by RP-HPLC. Asian Journal of Research Chemistry. 2019;12(3):136-142. Doi: http://dx.doi.org/10.5958/0974-4150.2019.00028.2
28. Kalyankar TM, Kakde RB. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Metformin and Repaglinide in Pharmaceutical Preparations. Research Journal of Pharmaceutical Dosage Forms and Technology. 2011;3(5):233-237.
29. Swapna J et al. Analytical method development and method validation for the simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride in tablet dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2012;2(3):85-89.