Advances in Pharmacology and Pharmacy Vol. 12(4), pp. 400 - 407
DOI: 10.13189/app.2024.120412
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Mahendra R. Mahajan 1, Dipak D. Patil 2,*, Ketan B. Patil 3
1 Department of Pharmaceutical Chemistry, H. R. Patel Institute of Pharmaceutical Education and Research, India
2 Department of Pharmaceutical Chemistry, K. K. Wagh College of Pharmacy, India
3 Department of Pharmaceutics, H. R. Patel Institute of Pharmaceutical Education and Research, India

ABSTRACT

In this work, we devised a practical and efficient RP-HPLC tactic for simultaneously estimating teneligliptin (TEN) and metformin (MET) in both pharmaceutical formulations and bulk substances. Our methodology involved the utilization of a reversed-phase Princeton SPHER-100 C18 column specification (150 × 4.6 mm, 5 μm particle size) as the stationary phase. Briefly, the mobile phase comprised a blend of 0.025 M potassium dihydrogen phosphate (KH2PO4) buffer (pH 4) and methanol in a ratio of 40:60, respectively. The recognition of the compounds was conducted at 249 nm wavelength, with a flow rate maintained at 1 mL/min. The developed approach exhibited excellent proportionality across concentration levels of 25-800 μg/mL for MET and 5–60 μg/mL for TEN, with high coefficients of determination (R2 = 0.9959 and 0.9958, respectively). Herein, retention times for MET and TEN were determined to be 1.28 and 4.82 minutes, correspondingly. Additionally, recovery rates for MET and TEN ranged from 99.36% to 99.78% and 93.77% to 95.46%, singly. Regarding sensitivity, the limits of detection (LOD) and limits of quantification (LOQ) for TEN were 8.19 µg/mL and 27.30 µg/mL, respectively, while for MET, they were 79.26 µg/mL and 264.20 µg/mL, respectively. The specificity of our tactic was assessed under numerous stress conditions, including exposure to 0.1 M HCl, 0.1 N NaOH, 3% H2O2, thermal conditions at 50℃, and UV radiation, demonstrating its robustness.

KEYWORDS
Metformin, Teneligliptin, Linearity, RP-HPLC

Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] Mahendra R. Mahajan , Dipak D. Patil , Ketan B. Patil , "Development of a Novel RP-HPLC Method for the Simultaneous Quantification of Teneligliptin and Metformin in Pharmaceutical Tablet Formulation," Advances in Pharmacology and Pharmacy, Vol. 12, No. 4, pp. 400 - 407, 2024. DOI: 10.13189/app.2024.120412.

(b). APA Format:
Mahendra R. Mahajan , Dipak D. Patil , Ketan B. Patil (2024). Development of a Novel RP-HPLC Method for the Simultaneous Quantification of Teneligliptin and Metformin in Pharmaceutical Tablet Formulation. Advances in Pharmacology and Pharmacy, 12(4), 400 - 407. DOI: 10.13189/app.2024.120412.