UV Spectroscopic Method Development and Validation for the Estimation of Metformin HCL in Pure and Its Marketed Tablets
DOI:
https://doi.org/10.22270/ajprd.v13i5.1617Abstract
The present research study was to Ultra Violet spectroscopy (UV) method develop and validatefor the quantification of model anti-diabetic drug Metformin HCl (MET) in pure formand marketed tablets. Different solvent blends were screened blend comprising of Acetonitrile: Methanol: DW at 1:1:1was selected and same was used for study. The validation is done as per ICH guidelines, validated for their accuracy, precision and robustness of the chosen solvent blend. The results show the linearity in the concentration range (1-50 µg/mL) with correlation coefficient R2 = 0.9989 with percent recovery (100 – 101.5 %) with RSD was less than 2%, LOD and LOQ 0.0433, 0.132µg/mL respectively. This method can show high quality and there is no significant interference with the excipients and in pharmaceutical forms. None of the studies showed the development of this method before.
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Viollet B, Guigas B, Sanz Garcia N, Leclerc J: Cellular and molecular mechanisms of metformin: an overview. Clin Sci (Lond). 2012 Mar;122(6):253-270
Rena G, Hardie DG, Pearson ER: The mechanisms of action of metformin. Diabetologia. 2017 Sep;60(9):1577-1585.
Rena G, Pearson ER, Sakamoto K: Molecular mechanism of action of metformin: old or new insights? Diabetologia. 2013 Sep;56(9):1898-1906. Marie AA, Yassin MG, Roshdy A. Stability indicating green micellar liquid chromatographic method for simultaneous analysis of Metformin in their tablets. BMC Chem 2025 21;19(1):175
Chhetri HP, Thapa P, Van Schepdael A. Simple HPLC-UV method for the quantification of Metformin in human plasma with one step protein precipitation. Saudi Pharm J 2014 ;22:483-487.
Kar M, Choudhury PK. HPLC method for estimation of metformin hydrochloride in formulated microspheres and tablet dosage form. Indian J Pharm Sci 2009;71(3):318-320.
Gedawy A, Al-Salami H, Dass CR. Development and validation of a new analytical HPLC method for simultaneous determination of the antidiabetic drugs, Metformin. J Food Drug Anal 2019;27(1):315-322.
El-Bagary RI, Elkady EF, Ayoub BM. Determination of Metformin Hydrochloride using High Performance Liquid Chromatography. Int J Biomed Sci 2013;9(1):41-47.
Thomas AB, Patil SD, Nanda RK, Kothapalli LP, Bhosle SS, Deshpande AD. Stability-indicating HPTLC method and Metformin hydrochloride in pharm dosage form. Saudi Pharm J 2011;19(4):221-231
Modi DK, Patel BH. Simultaneous determination of Metformin hydrochloride and Glipizide in tablet formulation by HPTLC. Journal of liquid chromat & related technologies 2012;35(1):28-39
Mohamed YA, Mohamed AM, Mohamed FA, Ahmed SA. New salting out stability-indicating and kinetic thin layer chromatographic method for determination of Metformin HCl binary mixture. J Chromat Sci 2015; 53(9):1603-1610.
Madhukar A, Prince A, Vijay Kumar R, Sanjeeva Y, Jagadeeshwar K, Raghupratap D.Simple and sensitive analytical method development and validation of metformin hydrochloride by RP-HPLC. Int J PharmaPharmSci 2011;3 (3): 117-120.
Vetapalem R, Yejella RP, Atmakuri LR. Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin. Turk J Pharm Sci 2020 (2):141-147
Marie AA, Hammad SF, Salim MM, Elkhodary MM, Kamal AH. Deduction of the operable design space of RP-HPLC technique for the simultaneous estimation of Metformin. Sci Rep 2023;13(1):4334.
Vaingankar PN, Amin PD. Development and Validation of Stability-Indicating RP-HPLC Method for Determination of Metformin HCl Fixed-Dose Combination. Anal Chem Insights. 2016;11:13-20.
Janardhan Swamy A, Harinadha Baba K. Analytical Method development and Method validation for the estimation of Metformin HCL and in Bulk and tablet Dosage Form by RP-HPLC Method. International Journal of Pharmacy 2013; 3(3): 594-600.
Vemula P, Dodda D, Balekari U, Panga S, Veeresham C. determination of Metformin by RP-HPLC Method. An application in quantitative analysis of pharmaceutical dosage forms J Adv Pharm Technol Res 2015 ;6(1):25-28
Gopal NM, Sridhar C. A validated stability indicating ultra performance liquid chromatographic method for simultaneous determination of Metformin hydrochloride drug and tablet dosage form. Int J of Applied Pharmaceutics 2017; 9(3):45-50
Vankalapati KR, Alegete P, Boodida S. Stability-indicating ultra performance liquid chromatography method development and validation for estimation of Metformin in bulk and pharmaceutical dosage form. Biomed Chromat 2021;35(4):5019
Arayne MS, Sultana N, Zuberi MH, Siddiqui FA. Spectrophotometric Quantitation of Metformin in Bulk Drug and Pharmaceutical Formulations using Multivariate Technique. Indian J Pharm Sci2009;71(3):331-335.
SenAK, HinsuDN, SenDB, ZanwarAS, MaheshwariRA, ChandrakarVR.Analytical method development and validation forestimation of Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods. Journal of Applied Pharmaceutical Science 2016; 6(9): 157-165.
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Copyright (c) 2025 Rishika Vaishnav, Vasavi Yadav, N. Srinivasulu, Y. Anand Kumar

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