Author(s):
Deepak Mandal, Manisha Trivedi, Meenakshi Dahiya, Robin Kumar, Dharam Pal Pathak, Nupur Tomar, Rajan Choudhary
Email(s):
rudrasanty2001@gmail.com , ipcmanisha@gmail.com , meenakshi.ipc@gov.in , robinkumar21@gmail.com , drdppathak@gmail.com , nupurtomar85@gmail.com , rajanchoudhary413@gmail.com
DOI:
10.52711/0974-360X.2026.00417 
Address:
Deepak Mandal1,2, Manisha Trivedi2, Meenakshi Dahiya2, Robin Kumar2, Dharam Pal Pathak1, Nupur Tomar2, Rajan Choudhary2
1,2Quality Assurance, Deepak Mandal, Delhi Pharmaceutical Science and Research University, New Delhi, India.
2Reference Standard Division, Dr. Manisha Trivedi, Indian Pharmacopoeia Commission, Ghaziabad, India.
2Quality Assurance Head, Dr. Meenakshi Dahiya, Indian Pharmacopoeia Commission, Ghaziabad, India.
2Reference Standard Division, Dr. Robin Kumar, Indian Pharmacopoeia Commission, Ghaziabad, India.
1Pharmaceutical Chemistry, Dr. Dharam pal Pathak, Delhi Pharmaceutical Science and Research University, New Delhi, India.
2Reference Standard Division, Dr. Nupur Tomar, Indian Pharmacopoeia Commission, Ghaziabad, India.
2Reference Standard Division, Mr. Rajan Choudhary, Indian Pharmacopoeia Commission, Ghaziabad, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 7,
Year - 2026
ABSTRACT:
Background: This study explores the pharmacological features of metformin hydrochloride and glimepiride, two widely recommended medicines for controlling type 2 diabetes mellitus. Objective: The primary objectives were to assess the dissolving profiles, confirm the uniformity of the active pharmaceutical components, and evaluate conformity to pharmacopoeial standards in branded and generic formulations. Methods: We employed UV spectroscopy and high-performance liquid chromatography (HPLC) to conduct extensive evaluations. The absorption profile of UV spectroscopy revealed the measurement of the concentration of the medication in different formulations. HPLC had provided precise separation and quantitation and proved the purity and concentration of various samples. The dissolving studies were performed to detect the differences in the release of branded and generic preparations. Univariate ANOVA, and t-tests were applied to determine consistency and reproducibility of data through statistical analysis. The use of Graphical representation and interpretation, non mathematical models (f1, f2, and the Rescigno ratio), mathematical models (zero order, first order, Higuchi, Pappas, Sahlin, Hixson-Crowell, Baker-Lader, Kos Meyer-Pappas) used to describe the dissolution profiles. Results: The dissolution studies showed there were major variations between the brand and generic formulations concerning the rate of release which could affect the bioavailability and efficacy of a drug. Consistency and trustworthiness were supported with the help of statistical study. In conclusion, our results emphasize the high importance of standard analytical measures in the process of ensuring drug quality and drug efficacy. The given work contributes insightful experience to the pharmaceutical analysis of the anti-diabetic medications, which benefit establishing the reliable formulations of generics and highlighting the importance of quality control in the pharmaceutical industry.
Cite this article:
Deepak Mandal, Manisha Trivedi, Meenakshi Dahiya, Robin Kumar, Dharam Pal Pathak, Nupur Tomar, Rajan Choudhary. Comparative Quality Assessment of Branded and Generic Metformin Prolonged-Release Tablets and Glimepiride Tablets using Assay, In-vitro Dissolution Testing and Statistical Approaches (Model-Dependent and Model-Independent Approaches). Research Journal of Pharmacy and Technology. 2026;19(7):2926-2. doi: 10.52711/0974-360X.2026.00417
Cite(Electronic):
Deepak Mandal, Manisha Trivedi, Meenakshi Dahiya, Robin Kumar, Dharam Pal Pathak, Nupur Tomar, Rajan Choudhary. Comparative Quality Assessment of Branded and Generic Metformin Prolonged-Release Tablets and Glimepiride Tablets using Assay, In-vitro Dissolution Testing and Statistical Approaches (Model-Dependent and Model-Independent Approaches). Research Journal of Pharmacy and Technology. 2026;19(7):2926-2. doi: 10.52711/0974-360X.2026.00417 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-7-4
8. REFERENCES:
1. Ghante M, Dargude S, Patil A, Bhusari V. Introduction: Quality Assurance from Perspective of Pharmaceutical Industry. In: Modern Aspects of Pharmaceutical Quality Assurance. Singapore: Springer Nature Singapore. 2024. p. 1–7.
2. Soumya K, Susanna S, Murthy TEGK. In vitro dissolution studies on commercial brands containing immediate release pioglitazone and metformin hydrochloride extended release tablets . Research Journal of Pharmaceutical Dosage Forms and Technology. 2017; 9(1).
3. Gomeni R, Bressolle-Gomeni F. Deconvolution Analysis by Non-linear Regression Using a Convolution-Based Model: Comparison of Nonparametric and Parametric Approaches. AAPS J. 2020 Jan 9;22(1):9.
4. Sun ML, Liu HJ, Luo XD, Wang Y, Zhang W, Liu C, et al. Bioequivalence and Safety Assessment of Two Formulations of Metformin Hydrochloride Sustained-Release Tablets (Yuantang® SR and Glucophage® XR) Under Fed Conditions in Healthy Chinese Adult Subjects: An Open-Label, Two-Way Crossover, Sequence Randomized Phase I Clinical Trial. Drugs R D. 2022 Mar 21;22(1):51–60.
5. Mamari R, Ibrahim R. The effect of Chronic treatments of Type 2-diabetes mellitus on COVID-19 Morbidity and Symptoms Severity. Res J Pharm Technol. 2023;16(11).
6. Manikandan M, Kannan K, Selvamuthukumar S, Manavalan R. Design, development and evaluation of Metformin Hydrochloride and Glimepiride immediate release tablets. Res J Pharm Technol. 2012; 5(4).
7. Proks P, Reimann F, Green N, Gribble F, Ashcroft F. Sulfonylurea Stimulation of Insulin Secretion. Diabetes. 2002 Dec 1;51(suppl_3):S368–76.
8. Jain A, Chaudhary J, Saini A, Mehan N. Quality assessment and comparative study of different marketed brands of metformin. Res J Pharm Technol. 2019; 12(3).
9. Gupta VK, Singh A, Gupta AK, Trigunayat A, Kumar B. A Pilot Study on Knowledge and Experience on use of Generic Medicines among Healthcare Professionals. Res J Pharm Technol. 2022; 15(12).
10. Parthiban C, Bhagavan Raju M, Sudhakar M. A novel simultaneous estimation of metformin, glimepiride and rosiglitazone in tablet dosage form by RP-HPLC method. Res J Pharm Technol. 2011; 4(10).
11. Sandhya SM, Shiji Kumar PS. Simple and rapid simultaneous rp-hplc method for determination of glimepiride and metformin in tablet dosage form. Res J Pharm Technol. 2014; 7(8).
12. Gholve R, Pekamwar S, Wadher S, Kalyankar T. Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form. Futur J Pharm Sci. 2021 Dec 4; 7(1): 224.
13. Bayas JP, Sumithra M. Analytical method development and validation of dasatinib in bulk and pharmaceutical formulation using quality by design. Res J Pharm Technol. 2021; 14(3).
14. Mohd AB, Sanka K, Gullapelly R, Diwan P V, Shastri N. Development and validation of RP-HPLC method for glimepiride and its application for a novel self-nanoemulsifying powder (SNEP) formulation analysis and dissolution study. J Anal Sci Technol. 2014 Dec 2; 5(1): 27.
15. Neelima K, Prasad YR. Analytical Method Development and Validation of Metformin, Voglibose, Glimepiride in Bulk and Combined Tablet Dosage Form by Gradient RP-HPLC. Pharm Methods. 2014 Jul 18; 5(1): 27–33.
16. Xiong K, Ma X, Cao N, Liu L, Sun L, Zou Q, et al. Identification, characterization and HPLC quantification of impurities in apremilast. Analytical Methods. 2016; 8(8): 1889–97.
17. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, et al. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019 Mar 13; 16(3): e1002763.
18. Cotia A, Oliveira Junior HA, Matuoka JY, Boszczowski Í. Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis. Antibiotics. 2023 May 21; 12(5): 935.
19. Baghel US, Sharma A, Gautam H, Mukim M, Singh D, Dave S, et al. Spectrophotometric Multi-Component Quantitation of Rosiglitazone, Glibenclamide and Metformin HCl in Pharmaceutical Dosages Form by using Cramer’s Matrix. Res J Pharm Technol. 2023; 16(12).
20. Yunita EP, Asriyanti NLPG, Gunawan A. Evaluation of Drug Combinations’ Effectiveness in Hyperkalemia Management of Chronic Kidney Disease Patients. Res J Pharm Technol. 2022; 15(1).
21. Karun KM, Deepthy MS. Generalized Estimating Equations in Longitudinal Studies: A Non-Parametric Alternative for Two-Way Repeated Measures Mixed ANOVA. Res J Pharm Technol. 2023; 16(5).
22. Zumbo BD. Univariate Tests. In: Encyclopedia of Quality of Life and Well-Being Research. Dordrecht: Springer Netherlands; 2014. p. 6819–20.