Author(s):
Arijit Dutta, Sowjanya Gummadi
Email(s):
duttaarijit2307@gmail.com
DOI:
10.52711/2231-5675.2024.00042 
Address:
Arijit Dutta*, Sowjanya Gummadi
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam, Andhra Pradesh, India, PIN-530045.
*Corresponding Author
Published In:
Volume - 14,
Issue - 4,
Year - 2024
ABSTRACT:
A simple, rapid, affordable, precise, and accurate RP-HPLC technique for simultaneous quantification of Remogliflozin Etabonate and Metformin HCL in their synthetic mixture and tablet dosage form has been devised. A reverse-phase high-performance liquid chromatographic method has been devised to simultaneously quantify Remogliflozin Etabonate and Metformin HCL in their Synthetic Mixture. Chromatographic separation was obtained using a Phenomenex Luna (250mm X 4.6mm, 5µm) C8 column with a mobile phase consisting of 0.1% v/v orthophosphoric acid and acetonitrile in the ratio of 30:70 % v/v, at a 0.9mL/min. Detection was carried out at 230nm. The retention time of Remogliflozin Etabonate and Metformin HCL was 4.63min and 2.09 min, respectively. Linearity was observed for Remogliflozin Etabonate 0.1-20µg/mL and for Metformin HCL 0.5-100µg/mL. The method devised for quickly, precisely, and accurately quantifying Metformin HCl and Remogliflozin Etabonate in their synthetic mixture was effective. Stress conditions that comprised hydrolysis, oxidation, thermal degradation and photolysis were applied. The suggested technique, which worked well for simultaneously quantifying both drugs in a commercial synthetic mixture.
Cite this article:
Arijit Dutta, Sowjanya Gummadi. Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin and Metformin in Marketed Dosage forms. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):234-0. doi: 10.52711/2231-5675.2024.00042
Cite(Electronic):
Arijit Dutta, Sowjanya Gummadi. Development and Validation of RP-HPLC Method for Simultaneous Quantification of Remogliflozin and Metformin in Marketed Dosage forms. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):234-0. doi: 10.52711/2231-5675.2024.00042 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-4-6
REFERENCES:
1. Napoleon A.A. Pharmaceutical Titrimetric Analysis theory and practical, Kalaimani Publishers and Distributors, 1.1-1.4.
2. S. Ashutosh Kar. Pharmaceutical Drug Analysis 2nd Edition, New Age International Private Limited Publishers, 2005; 452-474.
3. Beckett AH and Stenlake JB. Text Book of Practical Pharmaceutical Chemistry, Part II, C.B.S., Publishers and Distributors, 157-162.
4. Waller DG, Sampson AP, Renwick AG, Hiller K. Medical pharmacology and therapeutics; 4th edn, 457.
5. Anthony Markham. Remogliflozin etabonate: first global approval. 2019; 79(10): 1157-1161.doi:10.1007/s40265-019-01150-9.
6. Dutta D, Jindal R, Mehta D, Khandelwal D, Sharma M. Efficacy and Safety of Novel Sodium Glucose Cotransporter-2 inhibitor Remogliflozin in The Management of Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Diabetes Metab Syndr. 2011; 15(6). https://doi.org/10.1111/j.1463-1326.2011.01462.x
7. Sykes AP, O'Connor-Semmes R, Dobbins R, Dorey DJ, Lorimer JD, Walker S. Randomized trial showing efficacy and safety of twice-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes, Obesity and Metabolism. 2014; 17(1): 94-97. https://doi.org/10.1111/dom.12391
8. Sykes AP, Kemp GL, Dobbins R, O'Connor-Semmes R, Almond SR, Wilkison WO. Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes. Diabetes, Obesity and Metabolism. 2014; 17(1): 98-101. https://doi.org/10.1111/dom.12393
9. Avolynt Announces Completion of Phase 2b BRID Study of SGLT2 inhibitor Remogliflozin Etabonate. Avolynt, Inc. July 24, 2018.
10. George Fantus, R. Brossea. Mechanism of action of Metformin: insulin receptor and postreceptor effects in vitro and in vivo. The Journal of Clinical Endocrinology and Metabolism. 1986; 63(4): 898–905. doi: 10.1210/jcem-63-4-898.
11. S.M. Charjan, S.K. Bais, R.R. Shiradkar, R.L. Bakal, V.M. Durge, A.V. Chandewar. Comparative Evaluation of Quality Control Parameters of Marketed Antidiabetic Tablet. Research J. Pharm. and Tech. May 2011; 4(5): 801-805.
12. Nachiket S. Dighe, Ganesh S. Shinde, Jyoti. J. Vikhe. Simultaneous Estimation, Validation and Force Degradation Study of Metformin Hydrochloride and Empagliflozin by RP-HPLC Method. Research J. Science and Tech. 2019; 11(2): 135-147. DOI: 10.5958/2349-2988.2019.00021.4
13. Jayshree Pawar, Sandeep Sonawane, Santosh Chhajed, Sanjay Kshirsagar. Development and Validation of RP-HPLC method for simultaneous Estimation of Metformin HCl and Gliclazide. Asian J. Pharm. Ana. 2016; 6(3): 151-154. DOI: 10.5958/2231-5675.2016.00024.7
14. Khushbu Patel, Ujashkumar A. Shah, Hirak V. Joshi, Jayvadan K. Patel, Chhaganbhai N. Patel. QbD Stressed Development and Validation of Stability-Indicating RP- HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2022; 15(5): 1917-3. DOI: 10.52711/0974-360X.2022.00319
15. S. J. Daharwal, S Prakash Rao, Vijay Kumar Singh, Chandraprakash Dwivedi, Veena D. Singh. Comparative evaluation of marketed formulations of Metformin HCl. available in India. Asian J. Research Chem. 2015; 8(7): 441-444. DOI: 10.5958/0974-4150.2015.00070.X
16. Ravi Pratap Pulla, B.S. Sastry, Y. Rajendra Prasad, N. Appala Raju. Simultaneous Estimation of Metformin HCL and Sitagliptin Phosphate in Tablet Dosage Forms by RP-HPLC. Research J. Pharm. and Tech., 2011; 4(4): 646-649.
17. Ashok Kumar P, Suresh V Kulkarni, Basavaraj, Nikunj Patel, Someshwara Rao B, Ramesh B. Formulation and Evaluation of Locust Bean Gum Based Matrix Tablets for Oral Controlled Delivery of Metformin Hydrochloride and Its Comparison with Marketed Product. Research J. Pharm. and Tech. 2010; 3(4): 1082-1087.
18. Vitarani Dwi Ananda Ningrum, Ari Wibowo, Isma Fuaida, Zullies Ikawati, Ahmad Hamim Sadewa, Mohammad Robikhul Ikhsan. Validation of an HPLC-UV Method for the Determination of Metformin Hydrochloride in Spiked-human Plasma for the Application of Therapeutic Drug Monitoring. Research J. Pharm. and Tech., 2018; 11(6): 2197-2202. DOI: 10.5958/0974-360X.2018.00406.7
19. Inzucchi SE, Lipska KJ, Mayo H, Bailey CJ, McGuire DK. Metformin in patients with type 2 diabetes and kidney disease: a systematic review. 312(24): 2668–75. doi: 10.1001/ jama.2014.15298.
20. Diamanti-Kandarakis E, Economou F, Palimeri S, Christakou C. Metformin in polycystic ovary syndrome. Annals of the New York Academy of Sciences. 2010; 1205(1): 192–8. doi: 10.1111/j.1749-6632.2010.05679.x.
21. Diamanti-Kandarakis E, Christakou CD, Kandaraki E, Economou FN. Metformin: an old medication of new fashion: evolving new molecular mechanisms and clinical implications in polycystic ovary syndrome. European Journal of Endocrinology. 2010; 162(2): 193–212. doi: 10.1530/EJE-09-0733.
22. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009; 52(1): 17–30. DOI: 10.1007/s00125-008-1157-y.
23. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Medical Management of Hyperglycaemia In Type 2 Diabetes Mellitus: A Consensus Algorithm For The Initiation and Adjustment Of Therapy: A Consensus Statement From The American Diabetes Association and The European Association For The Study Of Diabetes. Diabetologia. 2009; 52(1): 17–30. DOI: 10.1007/s00125-008-1157-y.
24. Mahesh Attimarad, Anroop Balachandran Nair, Sreeharsha Nagaraja, Bandar Essa Aldhubiab, Katharigatta Narayanaswamy Venugopala, Shinu Pottathil. Smart UV derivative spectrophotometric methods for simultaneous determination of Metformin and Remogliflozin: development, validation and application to the formulation. Indian Journal of Pharmaceutical Education and Research. 2021; 55(1): 293-302. DOI: 10.5530/ijper.55.1s.62.
25. Shivani V. Trivedi. Stabilty indicating RP-HPLC method development and validation for simultaneous estimation of Remogliflozin Etabonate and Metformin Hcl in synthetic mixture and tablet dosage form. World Journal of Pharmaceutical Research. 2021; 10(1).
26. Ruchi Vasa, Nimit Vasa, Neha Tiwari, Pragnesh Patani, Bansi Solanki. Development and validation of stability indicating RP- HPLC method for estimation of Metformin Hcl and Remogliflozin Etabonate in pharmaceutical dosage form. International Journal of All Research Education and Scientific Methods. 2021; 9(1).
27. ICH Harmonized Tripartite Guideline; Stability Testing of New Drug Substances and New Drug Products Q1A (R2); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2003.
28. ICH Harmonized Tripartite Guideline; validation of analytical procedures of New Drug Substances and New Drug Products Q2 (R1); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2003.