Author(s):
Parixit Prajapati, Pankaj Kapupara, Hitesh Vekariya
Email(s):
parixitprajapati@gmail.com
DOI:
10.52711/0974-360X.2024.00867 
Address:
Parixit Prajapati1*, Pankaj Kapupara2, Hitesh Vekariya2
1Research Scholar, Department of Pharmaceutical Chemistry, School of Pharmacy, RK University, Rajkot, Gujarat, India.
2Professor, School of Pharmacy, RK University, Rajkot, Gujarat, India.
*Corresponding Author
Published In:
Volume - 17,
Issue - 12,
Year - 2024
ABSTRACT:
Recently, Vildagliptin and Remogliflozin together have become a viable treatment choice for diabetes. The invention of HPTLC (High Performance Thin Layer Chromatography) approach for the concurrent measurement of Vildagliptin (VILG) and Remogliflozin (REMO) in both their pure API (Active Pharmaceutical Ingredient) forms and in a commercially accessible formulation is shown in the present work. The method is robust, selective, sensitive, and fast. Utilizing a solvent solution consisting of toluene: ethyl acetate: methanol and glacial acetic acid (2.0: 6.0: 0.5: 0.1, v/v/v/v), the separation was successfully accomplished on silica gel F254. The chromatographic bands were observed at a wavelength of 250nm in short-wave ultraviolet light. With retention factor Rf values of 0.36 and 0.71 for REMO and VILG, correspondingly, proposed method showed clearly delineated spots.
Cite this article:
Parixit Prajapati, Pankaj Kapupara, Hitesh Vekariya. Simultaneous Analysis of Remogliflozin Etabonate and Vildagliptin in Tablets by HPTLC: Method Development and Validation. Research Journal Pharmacy and Technology. 2024;17(12):5697-1. doi: 10.52711/0974-360X.2024.00867
Cite(Electronic):
Parixit Prajapati, Pankaj Kapupara, Hitesh Vekariya. Simultaneous Analysis of Remogliflozin Etabonate and Vildagliptin in Tablets by HPTLC: Method Development and Validation. Research Journal Pharmacy and Technology. 2024;17(12):5697-1. doi: 10.52711/0974-360X.2024.00867 Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-12-4
6. REFERENCES:
1. International Diabetes Federation: Facts and figures [Internet]. Available from: https://idf.org/about-diabetes/diabetes-facts-figures.
2. Central Drugs Standard Control Organization. List of FDC and New Drugs Approved for Marketing in India [Internet]. Cdsco 2014. Available from: http://cdsco.nic.in/forms/ list.aspx?lid=1820&Id=11.
3. Vildagliptin [Internet]. Available from: https://go.drugbank.com/ drugs/DB04876.
4. Remogliflozin etabonate [Internet]. Available from: https://go.drugbank.com/drugs/DB12935.
5. Chandarana C, Kapupara P. Development and validation of HPTLC method for simultaneous quantification of Aspirin and Omeprazole in bulk and marketed formulation. Journal of Chemical and Pharmaceutical Research. 2019; 11(10): 76-83.doi.org/10.1093/chromsci/bmae012.
6. Rank M, Kapupara P, Shah K. Development and validation of stability indicating HPTLC method for pioglitazone hydrochloride and metformin hydrochloride. Research Journal of Pharmacy and Technology. 2016; 9(10): 1555-61. doi.org/10.5958/0974-360X.2016.00305.X.
7. Pawar J, Sonawane S, Chhajed S, Kshirsagar S. Development and Validation of RP-HPLC method for simultaneous Estimation of Metformin HCl and Gliclazide. Asian Journal of Pharmaceutical Analysis. 2016; 6(3): 151-4. doi.org/10.5958/2231-5675.2016.00024.7.
8. Parmar A, Sonawane S, Chhajed S, Kshirsagar S. Development and validation of RP-HPLC method for simultaneous estimation of ezetimibe and glimepiride in tablet dosage form. Asian Journal of Pharmaceutical Analysis. 2017; 7(3): 185-8. doi.org/ 10.5958/2231-5675.2017.00029.1.
9. Attimarad M, Venugopala KN, Al-Dhubiab BE, Elgorashe RE, Shafi S. Development of ecofriendly derivative spectrophotometric methods for the simultaneous quantitative analysis of remogliflozin and vildagliptin from formulation. Molecules. 2021; 26(20): 6160. doi.org/10.3390/ molecules26206160.
10. Attimarad M, Venugopala KN, Shafi S, Balgoname AA, Altaysan AI. Smart spectrophotometric method development for simultaneous estimation of antidiabetic drugs in formulations. Indian Journal of Pharmaceutical Education and Research. 2022; 56(1): 224–31. doi.org/10.5530/ijper.56.1.26.
11. Mandale DA, Shah C, Jatt R. Development and Validation of Novel RP-HPLC Method for the Simultaneous Determination of Remogliflozin and Vildagliptin in Bulk and in synthetic Mixture. J. Pharm. Res. Int. 2021; 33: 338-49. doi.org/10.9734/jpri/2021/ v33i40B32296.
12. Habib B, Mittha J. Quality evaluation of generic products of metformin and vildagliptin tablets. Asian Journal of Pharmaceutical Analysis. 2021; 11(4): 255-8. doi.org/10.52711/ 2231-5675.2021.00043.
13. Aher V, Mankar SD, Shinde GS. Review on analytical methods for estimation of vildagliptin in bulk and pharmaceutical dosage form. Research Journal of Science and Technology. 2021; 13(2): 157-62. doi.org/ 10.52711/2349-2988.2021.00024.
14. Patel V, Pandya C, Pandya A, Patel D, Patel Z. Novel UHPLC DAD Method for Simultaneous determination of Vildagliptin and Metformin in Bulk and its Tablet formulation. Research Journal of Pharmacy and Technology. 2021; 14(8): 4143-50. doi.org/ 10.52711/0974-360X.2021.00717.
15. Patel VP, Bhatt KA, Shah MM, Patil DM, Patel RS, Desai DM, Parmar PH. Development and Validation of spectrophotometric estimation of vildagliptin through Oxidative coupling reaction using MBTH reagent in Pharmaceutical dosage form. Research Journal of Pharmacy and Technology. 2021; 14(1): 62-6. doi.org/ 10.5958/0974-360X.2021.00012.3.
16. Dayoub LA, Amali F. Development of a new visible Spectrophotometric analytical method for determination of Vildagliptin in bulk and Pharmaceutical dosage forms. Research Journal of Pharmacy and Technology. 2020; 13(6): 2807-10. doi.org/10.5958/0974-360X.2020.00499.0.
17. Vidhi D, Patel P. Method development and validation of UV spectrophotometric estimation of remogliflozin etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021; 14(4): 2042-4. doi.org/ 10.52711/0974-360X.2021.00362.
18. Dhara V, Hetvi C. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Remogliflozin Etabonate and Vildagliptin in bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(2): 69-73. doi.org/ 10.52711/2231-5675.2023.00012.
19. ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). In: Prescrire International [Internet]. 2011. p. 278. Available from: https://database.ich.org/sites/default/files/Q2%28R1%29 Guideline.pdf.
20. Food and Drug Administration. (1994). Center for Drug Evaluation and Research. Reviewer guidance: validation of chromatographic methods. Silver Spring (MD): Centre for Drug Evaluation and Research.