ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ANALYSIS OF ANTI-DIABETIC DRUGS METFORMIN AND EVOGLIPTIN IN PURE AND MARKETED FORMULATION BY UV SPECTROSCOPY AND RP-HPLC

  • Unique Paper ID: 205427
  • Volume: 13
  • Issue: 1
  • PageNo: 6562-6575
  • Abstract:
  • Analytical Method Developments and Validations for the Quantitative Estimation of Metformin and Evogliptin in bulk form and Combined Pharmaceutical Dosage Forms by UV Spectroscopy and RP-HPLC methods. In UV method the maximum absorption of Metformin and Evogliptin was found to be 248nm and 265nm respectively. The UV Method was validated as per the ICH Guidelines. In HPLC method, the chromatographic conditions were successfully developed for the separation of Metformin and Evogliptin by using Altima C18 (4.6mm×150mm, 5.0 µm), flow rate was 1.0 ml/min, and mobile phase ratio was Methanol: TEA Buffer pH 4.5: Acetonitrile in the ratio of 50:25:25% v/v/v, detection wavelength was 258nm. The retention times of Metformin and Evogliptin were found to be 2.102mins and 3.537mins respectively. The % purity of Metformin and Evogliptin was found to be 99.6%. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Metformin and Evogliptin was found in concentration range of 5µg/ml-25µg/ml and 12.5µg/ml -62.5µg/ml and correlation coefficient (r2) was found to be 0.9993 and 0.9998. The precision study was precise, robust, and repeatable. Hence the suggested UV and RP-HPLC method can be used for routine analysis of Metformin and Evogliptin in bulk and pharmaceutical dosage form for both methods regarding following ICH guidelines.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{205427,
        author = {Husna Kanwal Qureshi and Tahniyath Saba},
        title = {ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ANALYSIS OF ANTI-DIABETIC DRUGS METFORMIN AND EVOGLIPTIN IN PURE AND MARKETED FORMULATION BY UV SPECTROSCOPY AND RP-HPLC},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {6562-6575},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=205427},
        abstract = {Analytical Method Developments and Validations for the Quantitative Estimation of Metformin and Evogliptin in bulk form and Combined Pharmaceutical Dosage Forms by UV Spectroscopy and RP-HPLC methods. In UV method the maximum absorption of Metformin and Evogliptin was found to be 248nm and 265nm respectively. The UV Method was validated as per the ICH Guidelines. In HPLC method, the chromatographic conditions were successfully developed for the separation of Metformin and Evogliptin by using Altima C18 (4.6mm×150mm, 5.0 µm), flow rate was 1.0 ml/min, and mobile phase ratio was Methanol: TEA Buffer pH 4.5: Acetonitrile in the ratio of 50:25:25% v/v/v, detection wavelength was 258nm. The retention times of Metformin and Evogliptin were found to be 2.102mins and 3.537mins respectively. The % purity of Metformin and Evogliptin was found to be 99.6%. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Metformin and Evogliptin was found in concentration range of 5µg/ml-25µg/ml and 12.5µg/ml -62.5µg/ml and correlation coefficient (r2) was found to be 0.9993 and 0.9998. The precision study was precise, robust, and repeatable. Hence the suggested UV and RP-HPLC method can be used for routine analysis of Metformin and Evogliptin in bulk and pharmaceutical dosage form for both methods regarding following ICH guidelines.},
        keywords = {Metformin and Evogliptin, UV, HPLC, Method Development, Validation, Accuracy.},
        month = {June},
        }

Cite This Article

Qureshi, H. K., & Saba, T. (2026). ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ANALYSIS OF ANTI-DIABETIC DRUGS METFORMIN AND EVOGLIPTIN IN PURE AND MARKETED FORMULATION BY UV SPECTROSCOPY AND RP-HPLC. International Journal of Innovative Research in Technology (IJIRT), 13(1), 6562–6575.

Related Articles