Author(s): Harsh H. Ladm, Ashvinkumar V. Dudhrejiya

Email(s): ladharsh020@gmail.com , ashvinvd@gmail.com

DOI: 10.52711/2349-2988.2025.00014   

Address: Harsh H. Ladm, Ashvinkumar V. Dudhrejiya
Smt. BNB Swaminarayan Pharmacy College, Salvav - Vapi, B.K Mody Govt. Pharmacy College, Rajkot.
*Corresponding Author

Published In:   Volume - 17,      Issue - 2,     Year - 2025


ABSTRACT:
A reversed-phase HPLC method was designed and validated to serve as a stability-indicating technique for the simultaneous quantification of Teneligliptin, Pioglitazone, and Metformin Hydrochloride in a combined dosage form. This method utilized a Dionex system with a Force scientific C18 column (5µm, 250mm × 4.6mm i.d.) and employed a mobile phase consisting of phosphate buffer (pH 3), methanol, and acetonitrile in a 70:25:05 (%v/v) ratio, with UV detection set at 238nm. The method exhibited linearity across the concentration ranges of 12.5-75 µg/ml for Metformin, 0.5-3.0µg/ml for Teneligliptin, and 0.375-2.25µg/ml for Pioglitazone. It was assessed for system suitability, precision, accuracy, linearity, robustness, and forced degradation, demonstrating its effectiveness in separating the active pharmaceutical ingredients (APIs) from their degradation products and its applicability for analyzing samples of Teneligliptin, Pioglitazone, and Metformin.


Cite this article:
Harsh H. Ladm, Ashvinkumar V. Dudhrejiya. Stability Indicating Method for Simultaneously Estimation of Teneligliptin, Pioglitazone and Metformin Hydrochloride in Combined Tablet Dosage form by RP-HPLC. Research Journal of Science and Technology. 2025; 17(2):101-8. doi: 10.52711/2349-2988.2025.00014

Cite(Electronic):
Harsh H. Ladm, Ashvinkumar V. Dudhrejiya. Stability Indicating Method for Simultaneously Estimation of Teneligliptin, Pioglitazone and Metformin Hydrochloride in Combined Tablet Dosage form by RP-HPLC. Research Journal of Science and Technology. 2025; 17(2):101-8. doi: 10.52711/2349-2988.2025.00014   Available on: https://rjstonline.com/AbstractView.aspx?PID=2025-17-2-1


REFERENCES:
1.    KD, Tripathi. Essentials of Medical Pharmacology. 7th ed. Jaypee Brothers Medical Publishers; 2013:258-260.
2.    Pallavi M, Patil N. HPLC Method Development: a Review. J Pharm Res Educ. 2017; 1:43-60.
3.    Ravisankar P, Naga Navya C, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm. 2015; 5(10): 2250-3013.
4.    International Conference on Harmonization. Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference on Harmonization. 2005:4-13.
5.    Itigimatha N, Chadchan KS, Yallur BC, Hadagali MD. Simple and sensitive RP-HPLC and UV spectroscopic methods for the determination   of remogliflozin etabonate in pure and pharmaceutical formulations. Turk J Pharm Sci. 2021: 38-55.
6.    Bakshi, M., and Singh, S. Development of validated stability-indicating assay methods-critical review. In Journal of Pharmaceutical and Biomedical Analysis. 2002; 28. www.elsevier.com/locate/jpba
7.    Shah DA, Gondalia A, Patel VB, Mahajan A, Chhalotiya UK. Stability indicating liquid chromatographic method for the estimation of remogliflozin etabonate. J Chem Metrol. 2020; 14(2): 25-32.
8.    R, Vasanthi. Analytical method development and validation for simultaneous estimation of teneligliptin and metformin by using RP-HPLC. World J Pharm Res. 2017; 6(8): 1280-1291.
9.    Gandla K, Kumar DS. Development of a novel stability indicating RP-HPLC method for simultaneous estimation of metformin hydrochloride and teneligliptin hydrobromide in bulk and combined. Innov Int J Med Pharm Sci. 2017; 2: 2-5.
10.    Merugu M, Vijey Aanandhi M. Stability indicating method development and validation of semaglutide by RP-HPLC in pharmaceutical substance and pharmaceutical product. Res J Pharm Technol. 2021; 14(3): 1385-1389.
11.    Jajula NVI, Pawar AK. Development and validation of stability indicating method for simultaneous estimation of paritaprevir, ombitasvir, and ritonavir in tablet dosage form. Res J Pharm Technol. 2023; 16(5): 2306-2310.
12.    Indira A, Sreedhar NY, Balakrishna D. A stability indicating method development of lopinavir and ritonavir in combined tablet dosage forms by RP-HPLC. Res J Pharm Technol. 2022; 15(2): 661-664.

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