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PHARMASPIRE - Volume 12, Issue 1, January-March, 2020

Pages: 11-15

Date of Publication: 14-Jun-2022

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UV spectrophotometric method development and validation for the estimation of metformin hydrochloride in bulk and formulations

Author: Adity Sharma, S. S. Ganti

Category: Pharmaceutics


Aim and Objective: The aim of the study was to develop simple, reliable, accurate, cost-effective, and precise UV method for the determination of metformin hydrochloride in bulk and formulation. Materials and Methods: From API, 1 mg/mL solution was prepared and further diluted to prepare working standard solutions. Distilled water was selected as a solvent due to greater solubility and lambda max observed at 232 nm. The method was validated as per ICH guidelines. Results: Linearity range and correlation coefficient were 2–10 mcg/mL and 0.9995, respectively. The percentage recoveries of all the brands of metformin hydrochloride formulations were found within the limit of 99–101% with %RSD of <2% which showed our method is reliable. The method was precise as the %RSD is <2%. The detection limit and quantification limit were obtained for the proposed developed method 0.1270 µg/mL and 0.3848µg/ mL, respectively. Conclusion: From the above results, we conclude that this can be used for routine quantitative assessment of this drug in bulk and formulations can be implemented successfully.

Keywords: Metformin hydrochloride, UV spectrophotometric, antidiabetic, method validation


1. American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2008;31 Suppl 1:S62-7.

2. Lemke TL, Willimas DA, Roche VF, William ZS. Foye’s principles of medicinal chemistry. New Delhi, India: Wolters Kluwer; 2008. p. 1-1377.

3. Shinde NC, Pawar PY, Balame VD. Spectrophotometric determination and validation of metformin hydrochloride and glimepiride in bulk and tablet dosage form. Int J Drug Res Technol 2016;6:115-9.

4. The Controller of Publications. The Indian Pharmacopoeia. 4th ed., Vol. 1. New Delhi: The Controller of Publications; 1996. p. 469.

5. Budavari S. The Merck Index. 13th ed. Whitehouse Station, NJ : Merck and Co. Inc.; 2001. p. 998.

6. Eurich DT, McAlister FA, Blackburn DF, Majumdar SR, Tsuyuki RT, Varney J, et al. Benefits and harms of antidiabetic agents in patients with diabetes and heart failure: Systematic review. BMJ 2007;335:497-501.

7. National Institute for Health and Clinical Excellence. Clinical Guideline 66: Diabetes Type 2. Bethesda: National Institute for Health; 2008.

8. Clinical Guidelines Task Force. International Diabetes Federation. “Glucose Control: Oral Therapy”. Global Guideline for Type 2 Diabetes. Brussels: International Diabetes Federation; 2007. p. 35-8.

9. Tripathi K. Essentials of Medical Pharmacology. 5th ed. New Delhi: Jaypee Brothers Medical Publishers; 2011. p. 254-73.

10. Hardman JG, Limbird LE. Goodman and Gilman’s: The Pharmacological Basis of Therapeutics. 10th ed. New York: McGraw-Hill Education; 2001. p. 1701-5.

11. Giannarelli R, Aragona M, Cappelli A. Reducing insulin resistance with metformin: The evidence today. Diabetes Metab 2003;29:6S28-35.

12. Gunton JE, Delhanty PJ, Takahashi SI, Baxter RC. Metformin rapidly increases insulin receptor activation in human liver and signals preferentially through insulin-receptor substrate-2. J Clin Endocrinol Metab 2003;88:1323-32.

13. Zhou G, Myers R, Li Y, Chen Y, Shen X, Fenyk-Melody J, et al. Role of AMPactivated protein kinase in mechanism of metformin action. J Clin Invest 2001;108:1167-74.

14. Padmaja N, Babu MS, Veerabhadram G. Development and validation of UV spectrophotometric method for simultaneous estimation of empagliflozin and metformin hydrochloride in bulk drugs and combined dosage forms. Pharm Lett 2016;8:207-13.

15. Squibb BM. US Food and Drug Administration. Glucophage (Metformin Hydrochloride Tablets) Label Information. United States: Food and Drug Administration; 2008.

16. Sowjanya P. RP-HPLC method development of metformin in pharmaceutical dosage form. Res Rev J Pharm Anal 2015;4:9-20.

17. Arayne M, Sultana N, Zuberi M. Development and validation of RP-HPLC method for the analysis of metformin. Pak J Pharm Sci 2006;19:231-5.

18. Kar M, Choudhury PK. HPLC method for estimation of metformin hydrochloride in formulated microspheres and tablet dosage form. Indian J Pharm Sci 2009;71:318-20.

19. Dange YD, Honmane SM, Bhinge SD, Salunkhe VR, Jadge DR. Development and validation of uv-spectrophotometric method for estimation of metformin in bulk and tablet dosage form. Indian J Pharm Educ Res 2017;51:S754-60.

20. Rote AR, Saudagar RB. Estimation of metformin hydrochloride by UV spectrophotometric method in pharmaceutical formulation. World J Pharm Sci 2014;2:1841-5.

21. Karim R, Poly N, Banoo R. Development and validation of UV spectroscopic method for the determination of metformin hydrochloride in tablet dosage form. Int J Pharm Sci Res 2012;3:3170-4.

22. Mubeen G, Noor K, Vimala MN. Spectrophotometric method for estimation of metformin hydrochloride. Indian J Pharm Sci 2009;71:100-2.

23. Reddy CH, Mubeen G, Pal M. HPTLC method for estimation of metformin hydrochloride. Biomed Pharmacol J 2008;1:445-8.

24. Havele S, Dhaneshwar S. Estimation of metformin in bulk drug and in formulation by HPTLC. J Nanomed Nanotechnol 2010;1:100-2.

25. Xavier CM, Basavaiah K. RP-UPLC development and validation of metformin hydrochloride in pure drug and pharmaceutical formulations. World J Pharm Pharm Sci 2015;4:1649-68.

26. Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. 5th ed. Kolkata: Himalaya Publishing House; 2002. p. 626-36.

27. Beckett AH, Stenlake J. The Practical Pharmaceutical Chemistry. Part 2. New Delhi: CBS Publishers and Distributors; 1997.

28. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. New York: Wiley-Interscience Publication; 1997.

29. Guidelines ICH. Validation of Analytical Procedures: Text and Methodology Q2 (R1). Vol. 11. Geneva, Switzerland: International Conference on Harmonization; 2005.