Author(s):
Priyadarshini Chaudhari, Mayur Prajapati, Jaimin Suthar, Vishvesh Panchal, Khushbu Patel, C. N. Patel
Email(s):
priyadarshinichaudhari02@gmail.com , khushbusspc@gmail.com
DOI:
10.52711/2231-5675.2025.00008
Address:
Priyadarshini Chaudhari1, Mayur Prajapati1, Jaimin Suthar1, Vishvesh Panchal1, Khushbu Patel2, C. N. Patel3
1Shri Sarvajanik Pharmacy College, Near Arvind Baug, Mehsana - 384001, Gujarat, India.
2Associate Professor, Department of Pharmaceutical Chemistry and Quality Assurance, Shri Sarvajanik Pharmacy College, Near Arvind Baug, Mehsana - 384001, Gujarat, India.
3Principal and Professor, Department of Pharmaceutical Chemistry and Quality Assurance, Shri Sarvajanik Pharmacy College, Near Arvind Baug, Mehsana - 384001, Gujarat, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 1,
Year - 2025
ABSTRACT:
Simultaneous method has been developed for the estimation of Metformin hydrochloride and Evogliptin tartrate in pharmaceutical dosage form. The linearity was found to be in concentration range of 2 – 12µg/mL and 0.999 correlation coefficient at 233 nm and 0.998 at 267nm for Metformin hydrochloride. The linearity for Evogliptin tartrate was found to be in concentration range of 20 – 120µg/mL. The correlation coefficient was found to be 0.981 at 233nm and 0.999 at 267nm. The accuracy was found to be in the range of 98.02% - 100.74% and 99.09% - 101.5% for MFH and EGT respectively. The limit of detection (LOD) was found to be 0.13µg/mL and 2.39µg/mL for MFH and EGT respectively. The limit of quantification (LOQ) was found to be 0.386µg/mL and 7.253µg/mL for MFH and EGT respectively. The proposed method can be used for the determination of Metformin hydrochloride and Evogliptin tartrate in pharmaceutical dosage form. The simultaneous UV–Visible method was eco- friendly, simple, precise and accurate as per ICH guidelines. The proposed method can be used in quality control for routine analysis of Metformin hydrochloride and Evogliptin tartrate in the pharmaceutical dosage forms.
Cite this article:
Priyadarshini Chaudhari, Mayur Prajapati, Jaimin Suthar, Vishvesh Panchal, Khushbu Patel, C. N. Patel. Spectrophotometric Method Development and Validation for Simultaneous Estimation of Metformin Hydrochloride and Evogliptin Tartrate in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2025;15(1):45-0. doi: 10.52711/2231-5675.2025.00008
Cite(Electronic):
Priyadarshini Chaudhari, Mayur Prajapati, Jaimin Suthar, Vishvesh Panchal, Khushbu Patel, C. N. Patel. Spectrophotometric Method Development and Validation for Simultaneous Estimation of Metformin Hydrochloride and Evogliptin Tartrate in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2025;15(1):45-0. doi: 10.52711/2231-5675.2025.00008 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2025-15-1-8
REFERENCES:
1. Viollet B, Guigas B, Sanz GN, Leclerc J, et al. Cellular and Molecular Mechanisms of Metformin: An Overview. Clinical Science (London). 2012; 122(6):253-70.
2. Hrishabh J, Saurabh C, Khinchi MP. An Overview on Diabetic Mellitus. Asian Journal of Pharmaceutical Research and Development. 2017; 5(3):1-11.
3. Sachan AK, Saurabh S, Kumar V, Kumari K. Comparative Study of Natural and Synthetic Superdisintegrants in Orodispersible Metformin Tablet. Asian Journal of Pharmaceutical Research and Development. 2019; 7(3):46-53.
4. Kassa A, Abrham T, Muluken N. Comparative in Vitro Evaluation of Different Brands of Metformin Hydrochloride Film Coated Tablets Marketed in Addis Ababa, Ethiopia. Asian Journal of Pharmaceutical Research and Development. 2020; 8(3):42-50.
5. Tomislav M. Metformin Chemistry. News Medical. 2023. available on https://www.news-medical.net/health/Metformin-Chemistry.aspx#:~:text=Metformin%20is%20a%20white%2C%20hygroscopic, insoluble%20in%20ether%20or%20chloroform.
6. Anthony MC. Evogliptin. New drug approval. 2015. available onhttps://newdrugapprovals.org/?s=evogliptin+ tartrate&submit=
7. PubChem (135395528). Evogliptin tartrate. National Centre for Biotechnology Information. 2024. available onhttps://pubchem.ncbi.nlm.nih.gov/compound/135395528
8. The Indian Pharmacopoeia, Government of India. Metformin Hydrochloride. Ministry of Health and Family Welfare the Indian Pharmacopoeia Commission, Ghaziabad. 2018.
9. Pandya, D. J., et al. Development and Validation of Bilastine in Tablet Dosage Form by Quality by Design Approach. Indian Journal of Pharmaceutical Sciences, 2024; 683(2):683–691.
10. Sufiyan Ahmad, Ansari Sajjad, Md. Rageeb Md. Usman, Mohammed Imran, Rashid Akhtar. Development and Validation of RP- HPLC Method for Simultaneous Estimation of Metformin and Miglitol in Bulk and Dosage Form. Asian J. Pharm. Res. 2017; 7(3): 139-147.
11. Patel, K., Shah, U.A. & Patel, C.N. Box–Behnken design-assisted optimization of RP-HPLC method for the estimation of evogliptin tartrate by analytical quality by design. Futur J Pharm Sci. 2023; 9:57. https://doi.org/10.1186/s43094-023-00509-w
12. Vijaya Vichare, Pallavi Suryawanshi, Jyoti Bhosale, Shashikant Dhole. Simultaneous Estimation of Metformin HCl and Pioglitazone HCl by Second Order Derivative UV-Visible Spectrophotometric Method in Tablet Formulation. Asian J. Pharm. Ana. 2014; 4(3): 121-124.
13. Maha F. Abdel-Ghany, Miriam F. Ayad, Mariam M. Tadros. A Mini-Review of Spectrophotometric and Chromatographic Analysis and Bioanalysis of Selected Recently Approved Anti-Diabetic Combinations. Research J. Pharm. and Tech. 2017; 10(9): 3161-3172.
14. Amar Gangadhar Zalte, Ravindranath Bhanudas Saudagar, Pramod Nanasaheb Katkade. Validated UV- Spectroscopic estimation of Linagliptin Concentration in Bulk and Dosage form. Research J. Pharm. and Tech. 2016; 9(5): 490-492.
15. 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.
16. Saroj Gajare, Amar Zalte, Ravindra B. Saudagar. Simultaneous Spectrophotometric Determination of Linagliptin and Metformin Hydrochloride in Combined Tablet Dosage Form. Asian J. Pharm. Ana. 2017; 7(2): 79-83.
17. Gandla. Kumara Swamy, R. Lalitha, Ch. Mounika, B. Soumya, D. Sudheer Kumar. A Validated RP-HPLC Method for Simultanious Determination of Metformin and Canagliflozin in Pharmaceutical Formulation. Asian J. Pharm. Ana. 2018; 8(2): 73-77.
18. T. Naga Ravi Kiran, P. Parvathi, J.N. Suresh Kumar. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Linagliptin, Empagliflozin and Metformin in Solid Dosage Forms. Asian J. Pharm. Ana. 2020; 10(3):117-124.
19. Patel K, Shah UA, Joshi H, Patel CN. Derivative spectrophotometric method development and validation for the estimation of Evogliptin tartrate in pharmaceutical dosage form. Indian J Pha Ed Res. 2023; 57(1):228-33.
20. Khushbu K. Patel, Arati M. Patel, C. N. Patel. A new simple RP-HPLC Method development, Validation and Forced degradation studies of Bilastine. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 183-7.
21. 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.
22. Priyadarshini Chaudhari et al. Review on Analytical Method Development and Validation for Evogliptin Tartrate and Metformin Hydrochloride. IJPPR. Human, 2024; 30(1): 340-357.
23. Agrawal YP, Agrawal MY, Jadhav SB, Shinde RJ. Development and Validation of Novel UV Spectrophotometric method for the Determination of Evogliptin Tartrate in Pharmaceutical dosage form. Indian Journal of Pharmaceutical Education and Research. 2020; 54(4): 1174-9.
24. Arpit P, Rakesh P and Priyanka Y. Development and Validation of RP-HPLC method for Estimation of Evogliptin in Pharmaceutical dosage form. International Journal of Pharmaceutical Research and Application 2021; 6(2): 775-781.
25. Hetvi MA, Dulendra PD, Sachin BN. Development and Validation Stability Indicating RP-HPLC method for the Estimation of Evogliptin Tartrate in Pharmaceutical dosage form. International Journal of Pharmaceutical Science Review and Research. 2022; 72(2): 1-6.