Author(s):
Satish Shelke, Nital Ingle, Ashish Tale, Balaji Thakare, Rahul Kalwe, Shirish Jain
Email(s):
balaji.thakare2@gmail.com , shelkesp21@gmail.com , jayshree.thakare33@gmail.com , ashishtale93@gmail.com , rahulkalwe20@gmail.com , ashishtale93@gmail.com
DOI:
10.52711/2231-5713.2024.00048
Address:
Satish Shelke1, Nital Ingle1, Ashish Tale1, Balaji Thakare2*, Rahul Kalwe2, Shirish Jain1
1Department of Quality Assurance, Rajarshi Shahu College of Pharmacy, Buldhana 443001 (M.S.), India.
2Anuradha College of Pharmacy, Chikhali, Dist. Buldana (M.S.), India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 4,
Year - 2024
ABSTRACT:
A combination of Metformin and Evogliptin is used to treat type 2 diabetes mellitus. A selective, accurate and precise RPHPLC method was developed and validated for simultaneous estimation of these drugs in bulk and tablet dosage forms. The drugs were resolved on a C18 (150mm × 4.6mm, 5µ) column using Acetonitrile: water (75:25 v/v) as the mobile phase. The detection wavelength was 226 nm. The retention times obtained for metformin and evogliptin were 1.187 and 2.273 min respectively. The linearity ranges were 250-1250 and 2.5-12.5 µg/ml respectively with Regression coefficients of 0.9974 and 0.9994. The % RSD of precision studies was found to be less than 2%. The Accuracy of the proposed method was determined by recovery studies and the mean recovery was found to be in between 98-102%. The method was also applicable for quantitative analyses of the marketed tablet formulations and in studying stability of the drugs under acidic, alkaline, oxidation, thermal and UV conditions.
Cite this article:
Satish Shelke, Nital Ingle, Ashish Tale, Balaji Thakare, Rahul Kalwe, Shirish Jain. Development and Validation of Stability Indicating RP-HPLC Method for Evogliptin and Metformin in Bulk and Tablets. Asian Journal of Pharmacy and Technology. 2024; 14(4):299-6. doi: 10.52711/2231-5713.2024.00048
Cite(Electronic):
Satish Shelke, Nital Ingle, Ashish Tale, Balaji Thakare, Rahul Kalwe, Shirish Jain. Development and Validation of Stability Indicating RP-HPLC Method for Evogliptin and Metformin in Bulk and Tablets. Asian Journal of Pharmacy and Technology. 2024; 14(4):299-6. doi: 10.52711/2231-5713.2024.00048 Available on: https://ajptonline.com/AbstractView.aspx?PID=2024-14-4-1
9. REFERENCES:
1. Arun Chaudhury, Chitharanjan Duvoor, Vijaya Sena Reddy Dendi, Shashank Kraleti, Aditya Chada, Rahul Ravilla, Asween Marco, Nawal Singh Shekhawat, Maria Theresa Montales, Kevin Kuriakose, Appalanaidu Sasapu, Alexandria Beebe, Naveen Patil, Chaitanya K. Musham, Govinda Prasad Lohani and Wasique Mirza. Clinical review of antidiabetic drugs: implication for type 2 diabetes mellitus management. Frontiers in Endocrinology. January 2017; 8(6): 1-12.
2. 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.
3. M. Manikandan, K. Kannan, S. Selvamuthukumar, R. Manavalan. Design, Development and Evaluation of Metformin Hydrochloride and Glimepiride Immediate Release Tablets. Research J. Pharm. and Tech. April 2012; 5(4): 547-552.
4. Yujun Wan, Xiaojua Xa, Robert G Glibert, Mitchell A Sullivan. A Review on the structure and antidiabetic (type 2) gunctions of β-Glucans. Foods. 2022; 11: 57. https://doi.org/10.3390/ foods11010057.
5. Syed Azhar Nizami, Vazir Ashfaq Ahmed, SC Marihal. Simultaneous Spectrophotometric Analysis of Glimiperide, Metformin and Piogilitazone HCl in Combined Dosage Form. Research J. Pharm. and Tech. 2010; 3(2): 518-521.
6. Shrikrishna B. Baokar, Sugandha V. Mulgund, Nisharani S. Ranpise. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin. Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 95-98.
7. Lata Kothapalli, Shivaji Mare, Veeren Dewoolkar, Anupam Banerjee, Asha Thomas, RK Nanda, AD Deshpande. Simultaneous RP-HPLC Method for Estimation of Metformin Hydrochloride and Fenofibrate in Synthetic Mixture. Research J. Pharm. and Tech. 2009; 2(4): 694-697.
8. AndreJ. Scheen. Clinical Pharmacokinetics of Metformin. Clln Pharmacokinet. 1996; 30(5): 359-371.
9. Enrique Z. Fisman1 and Alexander Tenenbaum et al. Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes. Fisman and Tenenbaum Cardiovasc Diabetol. 2015; 14: 129.
10. Deepa R. Patel, Laxmanbhai J. Patel, Madhabhai M. Patel. Stability Indicating HPLC Method for Simultaneous Determination of Repaglinide and Metformin Hydrochloride in Pharmaceutical Dosage Form. Asian J. Research Chem. March 2011; 4(3): 500-505.
11. Kapil Rana, Pushpendra Sharma. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology. 2021; 13(2): 111-8.
12. Deepan T, Rao MB, Dhanaraju MD. Development of validated stability indicating assay method for simultaneous estimation of metformin and dapagliflozin by RP-HPLC. Euro Jour App Sci. 2017; 9(4): 189-99.
13. Ashutosh KS, Manidipa D, Seshagiri RJ, Gowri SD. New validated stability indicating RP-HPLC method for simultaneous estimation of metformin and alogliptin in human plasma. J Chromatogr Sep Tech. Jun., 2015; 6(6): 1-6.
14. Sudheer Kumar Sapavat, V. Mohan Goud, J.V.C Sharma. Method Development and Validation for Simultaneous estimation of Metformin HCL and Sitagliptin by RPHPLC in Tablet Dosage Form. Int Jour Pharm and Ana Res. Jan-Mar., 2014; 3(1): 127-134.
15. Swapnil D. Jadhav, Akshay A. Magdum, Ramchandra M. Panchal, Pradip S. Koli. Simultaneous Estimation of Metformin Hydrochloride and Rosiglitazone Maleate from Tablet Dosage Form by Derivative Spectroscopic Method. Asian J. Pharm. Ana. July-Sept. 2013; 3(3): 94-97.
16. Ganesh S Shinde, Godge Rahul K, Ravindra Jadhav. Quantitative Estimation and Validation of Metformin Hydrochloride and Gliclazide in their Tablet Dosage Form by RP-HPLC. Research J. Science and Tech. 2019; 11(3): 201-207.
17. Dayyih WA, Hamad M, Mallah E, Abu Dayyih A, Awad R. METHOD Development and Validation of Vildagliptin and Metformin HCl in Pharmaceutical Dosage form by Reversed Phase-High Performance Liquid Chromatography (RP-HPLC). IJPSR. 2018; 9(7): 2965-721.
18. 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.
19. T.M. Kalyankar, R.B. Kakde. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Metformin and Repaglinide in Pharmaceutical Preparations. Research J. Pharma. Dosage Forms and Tech. 2011; 3(5): 233-237.
20. Dong-A ST’s DPP-4 inhibitor SUGANON, got approved for diabetes in Korea, 2 oct 2015. https://pipelinereview.com/ index.php/2015100259148/Small-Molecules/Dong-ASTs-DPP4-inhibitor-SUGANON-got-approved-for-type-2-diabetes-in-Korea.html
21. Kumar DV, Rao JS. A new validated stability indicating RP-HPLC method for simultaneous estimation of metformin hydrochloride and empagliflozin in tablet dosage forms. IRJPMS. 2018; 1: 16-22.