Application of Fourier Transform Infrared Spectrophotometry Method for Analysis of Metformin Hydrochloride in Marketed Tablet Dosage Form

Nerdy Nerdy, Linda Margata, Dian Ika Perbina Meliala, Bunga Mari Sembiring, Selamat Ginting, Effendy De Lux Putra, Atika Mulyati, Tedy Kurniawan Bakri


The first line drug given for monotherapy for diabetes mellitus type 2 is metformin hydrochloride, which is a biguanide antihyperglycemic drug. The aim of this research was to develop, validate, and apply the Fourier Transform Infrared spectrophotometry method to identify and determine metformin hydrochloride in marketed tablet dosage form. This research included preparation of standard, analysis of samples, and validation of method. The specific wavenumber obtained for qualitative analysis was 1645.68 cm–1 and 1574.8 cm–1. The specific area obtained for quantitative analysis with a single baseline ranged from 1701.53 cm–1 to 1535.66 cm–1. All metformin hydrochloride marketed tablet dosage forms were analyzed and met all of the qualitative and quantitative requirements. The methods met the requirements of method validation for accuracy with a percentage of recovery of 100.22 %, precision with relative standard deviation of 0.48 %, linearity with a correlation coefficient of 0.9992, limit of detection of 11.17 mg per mL, limit of quantitation of 33.84 mg per mL, and good specificity results. In this study, the Fourier Transform Infrared spectrophotometry method was successfully developed and validated for application in identification and determination of metformin hydrochloride in marketed tablet dosage form.


metformin hydrochloride, infrared, spectrophotometry, qualitative, quantitative


Adegoke OA. 2012. Chemical Derivatization Methodologies for UV‐Visible Spectrophotometric Determination of Pharmaceuticals. International Journal of Pharmaceutical Sciences Review and Research. 14(2): 6‐24.

Aggarwala A, Aeranb H, and Rathee M. 2019. Quality Management in Healthcare: The Pivotal Desideratum. Journal of Oral Biology and Craniofacial Research. 9(2): 180-182. DOI: 10.1016/j.jobcr.2018.06.006

Ahmad NR. 2012. Facial Visible Spectrophotometric Determination of Metformin Hydrochloride in Glucosam Tablets and Industrial Waste Water: Application to Content Uniformity Testing. Iraqi Journal Pharmacy. 12(1): 75-85. DOI: 10.33899/iphr.2012.62346

Assali M, Abualhasan M, Zohud N, and Ghazal N. 2020. RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine. International Journal of Analytical Chemistry. 2020; 2020 (7): 1894907. DOI: 10.1155/2020/1894907

Bansal R, Singh R, and Kaur K. 2021. Quantitative Analysis of Doxorubicin Hydrochloride and Arterolane Maleate by Mid IR Spectroscopy Using Transmission and Refectance Modes. BMC Chemistry. 15(1): 27. DOI: 10.1186/s13065-021-00752-3

Benmessaoud I, Koutchoukali O, Bouhelassa M, Nouar A, and Veesler S. 2016. Solvent Screening and Crystal Habit of Metformin Hydrochloride. Journal of Crystal Growth. 451(7): 42-51. DOI: 10.1016/j.jcrysgro.2016.07.001

Dange YD, Honmane SM, Bhinge SD, Salunkhe VR, Jadge DR. 2017. Development and Validation of UV-Spectrophotometric Method for Estimation of Metformin in Bulk and Tablet Dosage Form. Indian Journal of Pharmaceutical Education and Research. 51(4S): S754-S760. DOI: 10.5530/ijper.51.4s.109

Dong MW. 2013. The Essence of Modern HPLC: Advantages, Limitations, Fundamentals, and Opportunities. LCGC North America. 31(6): 472-479.

Fogel DB. 2018. Factors Associated with Clinical Trials that Fail and Opportunities for Improving the Likelihood of Success: A Review. Contemporary Clinical Trials Communications. 11(8): 156-164. DOI: 10.1016/j.conctc.2018.08.001

Gedawy A, Al-Salami H, and Dass CR. 2019. Development and Validation of a New Analytical HPLC Method for Simultaneous Determination of the Antidiabetic Drugs, Metformin and Gliclazide. Journal of Food Drug Analysis. 27(7): 315-322. DOI: 10.1016/j.jfda.2018.06.007

Kuete I, Tchuifon D, Ndifor-Angwafor G, Kamdem A, and Anagho S. 2020. Kinetic, Isotherm and Thermodynamic Studies of the Adsorption of Thymol Blue onto Powdered Activated Carbons from Garcinia cola Nut Shells Impregnated with H3PO4 and KOH: Non-Linear Regression Analysis. Journal of Encapsulation and Adsorption Sciences. 10(3): 1-27. DOI: 10.4236/jeas.2020.101001

Marín-Peñalver JJ, Martín-Timón I, Sevillano-Collantes C, and del Cañizo-Gómez FJ. 2017. Update on the Treatment of Type 2 Diabetes Mellitus. World Journal of Diabetes. 7(17): 354-395. DOI: 10.4239/wjd.v7.i17.354

Marson BM, Concentino V, Junkert AM, Fachi MM, Vilhena RO, and Pontarolo R. 2020. Validation of Analytical Methods in A Pharmaceutical Quality System: An Overview Focused on HPLC Methods. Quimica Nova. 43(8): 1190-1203. DOI: 10.21577/0100-4042.20170589

Marson BM, de Oliveira Vilhena R, de Souza Madeira CR, Pontes FLD, Piantavini MS, and Pontarolo R. 2016. Simultaneous Quantification of Artesunate and Mefloquine in Fixed-Dose Combination Tablets by Multivariate Calibration with Middle Infrared Spectroscopy and Partial Least Squares Regression. Malaria Journal. 15(1):109. DOI: 10.1186/s12936-016-1157-1

Mata-Miranda MM, Guerrero-Ruiz M, Gonzalez-Fuentes JR, Hernandez-Toscano CM, Garcia-Andino JR, Sanchez-Brito M, and Vazquez-Zapien GJ. 2019. Characterization of the Biological Fingerprint and Identification of Associated Parameters in Stress Fractures by FTIR Spectroscopy. BioMed Research International. 2019(9): 1241452. DOI: 10.1155/2019/1241452

Mendes E, and Duarte N. 2021. Mid-Infrared Spectroscopy as a Valuable Tool to Tackle Food Analysis: A Literature Review on Coffee, Dairies, Honey, Olive Oil and Wine. Foods. 10(2): 477. DOI: 10.3390/foods10020477

Ministry of Health Republic of Indonesia. Indonesian Pharmacopoeia. 6th Edition. 2020: Indonesia. Jakarta. 1130-1132

Mounika P, Padmavathi Y, Anjali A, and Reddy NP. 2018. Quantitative Estimation of Atorvastatin Calcium in Bulk and Tablet Dosage Forms Using FTIR Spectroscopy. International Journal of Pharma and Bio Sciences. 9(2): 221-232. DOI: 10.22376/ijpbs.2018.9.2.p221-232

Ouhaddouch H, Cheikh A, Idrissi MOB, Draoui M, and Bouatia M. 2019. FT-IR Spectroscopy Applied for Identification of a Mineral Drug Substance in Drug Products: Application to Bentonite. Journal of Sepctroscopy. 2019(3): 2960845. DOI: 10.1155/2019/2960845

Padmavathi Y, Chilka R, and Tummala R. 2020. Development and Validation of FTIR Spectroscopic Method for Simultaneous Estimation of Telmisartan and Hydrochlorothiazide in Pure and Pharmaceutical Dosage Forms. International Journal of Pharmaceutical Sciences and Research. 11(2): 862-872. DOI: 10.13040/IJPSR.0975-8232.11(2).862-72

Pinto IC, Cerqueira-Coutinho C, de Freitas ZMF, dos Santos EP, do Carmo FA, Junior ER. 2017. Development and validation of an analytical method using High Performance Liquid Chromatography (HPLC) to determine ethyl butylacetylaminopropionate in topical repellent formulations. Brazilian Journal of Pharmaceutical Sciences. 2017; 53(2):e16033. DOI: 10.1590/s2175-97902017000216033

Ramakrishna UV, Shyam SR, Rajesh KK, Sukesh NS. 2020. Method development and validation for rapid identification of epigallocatechin gallate using ultra-high performance liquid chromatography. Plos One. 15(1): e0227569. DOI: 10.1371/journal.pone.0227569

Ramalingam P, Reddy YP, Kumar KV, Chandu BR, and Rajendran K. 2014. Evaluation of Metformin Hydrochloride in Wistar Rats by FTIR‑ATR Spectroscopy: A Convenient Tool in the Clinical Study of Diabetes. Journal of Natural Science, Biology and Medicine. 5(2): 288-292. DOI: 10.4103/0976-9668.136168

Rena G, Hardie DG, and Pearson ER. 2017. The Mechanisms of Action of Metformin. Diabetologia. 60(8): 1577-1585. DOI 10.1007/s00125-017-4342-z

Robaina NF, de Paula CER, Brum DM, de la Guardia M, Garrigues S, Cassella RJ. 2013. Novel Approach for the Determination of Azithromycin in Pharmaceutical Formulations by Fourier Transform Infrared Spectroscopy in Film through Transmission Mode. Microchemical Journal. 110(5): 301-307. DOI: 10.1016/j.microc.2013.04.015

Sengul U. 2016. Comparing determination methods of detection and quantification limits for aflatoxin analysis in hazelnut. Journal of Food Drug Analysis. 24(5): 56-62.

Seo KS, Bajracharya R, Lee SH, and Han HK. 2020. Pharmaceutical Application of Tablet Film Coating. Pharmaceutics. 12(9): 853. DOI: 10.3390/pharmaceutics12090853

Shaikh M, and Jadhav AP. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gallic Acid, Curcumin and Piperine in an Ayurvedic Formulation. International Journal of Pharmacy and Pharmaceutical Sciences. 12(6): 81-86. DOI: 10.22159/ijpps.2020v12i6.33801

Full Text: PDF

DOI: 10.15408/jkv.v7i2.22158


  • There are currently no refbacks.

Copyright (c) 2021 Nerdy Nerdy, Linda Margata, Dian Ika Perbina Meliala, Bunga Mari Sembiring, Selamat Ginting, Effendy De Lux Putra, Atika Mulyati, Tedy Kurniawan Bakri

Creative Commons License
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.